Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.

Job Summary:

As a key member of the cross-functional Development Team responsible for providing regulatory writing expertise and leadership to formulate the writing strategy for key regulatory documents for submission. The Sr. Director, Head of Regulatory & Medical Writing will be responsible for providing guidance to the medical and or regulatory writing group (contractors and internal writers) assigned to deliverables and ensuring appropriate work allocation and document preparation.; will also provide review and substantive editing of documents to ensure delivery of high-quality documents. This individual will work effectively with many other functional groups, including with Clinical Scientist(s), Medical Monitors, Regulatory and other functions as applicable, and collaborate with clinical medical writing as applicable to ensure scientific excellence in the execution of clinical trials. The Head of Regulatory Writing will build a medical writing group internally when appropriate.

Reporting to the SVP, Head of Regulatory Affairs, this role will be responsible for the regulatory writing & medical writing deliverables of assigned project(s), in accordance with the agreed timelines and quality standards.

Responsibilities:

• Ensure appropriate allocation of internal and external resources needed for all regulatory writing deliverables.
• Hire and manage medical writers internally and manage external medical writing contractors.
• Forecasting and maintaining budget for the regulatory writing team.
• Assess efficiencies, help identify areas of improvement and initiate improvement processes.
• Coordinate, author and edit documents used to support clinical trial conduct and reporting including but not limited to:
• Clinical study protocols and clinical protocol amendments (in partnership with Clinical Science/Clinical Development)
• Clinical study reports
• Investigator’s brochures and annual updates
• IND submissions and annual reports
• Lay-person summary
• Integrated summary reports
• Clinical, Nonclinical and Multidisciplinary Information Amendments
• NDA, BLA, MAA, (e)CTD submissions
• Risk Management Plans
• Health Authority responses
• Briefing Documents, ODDs, BTDs/PRIME, FTD etc
• Participate in relevant subteam(s) and ensure effective planning and management of timelines for all components of assigned documents across all projects.
• Participate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects.
• Support and develop deliverables required for global transparency and disclosure requirements (e.g., plain language lay summary, applicable redactions to regulatory documents subject to EU posting regulations and results for EU CTR).Partner with Biometrics in developing standard TFLs and in text tables for deliverables as applicable
• Maintain and support developing and reviewing standard processes and templates.
• Review and edit documents as required.
• Work effectively and lead in cross-functional working groups.

Qualifications:

• Candidates must have a BS with 15+ years, or MS or other advanced science degree (e.g.: RN, NP, MSN, PharmD, PhD, MD) with 10+ years of experience in oncology clinical research experience as a clinical or regulatory medical writer within the pharmaceutical/biotech industry.
• Prior experience leading a regulatory writing group
• Experience writing/leading the writing of critical clinical documents in major regulatory filings (NDA, BLA, MAA).
• Proficiency in the use and understanding of computer software e.g. word processing, graphics, reference manager, document management systems.
• Familiarity with all phases of drug development processes (discovery to market), clinical study protocol design, CTA/IND submissions, investigator’s brochures and clinical study data collection and results reporting.
• Advanced knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and regulatory guidance documents and templates.
• Experience writing, at a minimum, protocols (Phase 1-3, in oncology), investigator’s brochures, clinical study reports, Health Authority briefing packages, and Health Authority responses. Experience with Pediatric Investigational Plans (PIPs) is preferred.
• Advanced understanding/knowledge of regulatory requirements and drug development processes, Good Clinical Practice (GCP), regulatory requirements and guidelines associated with regulatory documents (e.g., protocols, investigator brochures, and clinical study reports).
• Ability to interpret and summarize complex tabular and graphical data presentations.
• Strong organization, documentation and communication skills with an ability to multitask.
• Adaptable / flexible, willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism.
• Detailed knowledge of GCP, ICH Guidelines and current US FDA regulations.

Nurix Therapeutics, Inc. is committed to protecting and respecting your privacy and personal information, including information collected by Nurix when you apply for a job with Nurix or in the course of your employment with Nurix. By applying for a position at Nurix, you agree to our collection and use of personal information as described in our Privacy Policy (https://www.nurixtx.com/privacy-policy/).

Position Title:  

Associate Director, Regulatory Affairs (Strategy, Hematology Oncology)

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.

Job Summary:

Nurix Therapeutics, Inc. is seeking a Manager/Sr. Manager/Associate Director, Regulatory Affairs (Strategy, Hematology Oncology) to join the Regulatory team.  The successful candidate will be a core member of the Regulatory team and will be responsible for helping build and execute on global regulatory strategy, objectives, policies and programs pertaining to development and future marketing of products for guiding and executing upon regulatory strategy of compliant, high quality, nonclinical and clinical submissions and interactions in support of early development, registration and life cycle management activities. This includes supporting regulatory activities to enable clinical development plans and studies, working cross-functionally across the organization.

Responsibilities:

• Provides regulatory strategic direction and support for assigned global development programs/development program activities
• Assists Sr. Regulatory Affairs staff with their development program activities and deliverables
• Designs and implements regulatory strategies with Regulatory Affairs staff to obtain and maintain product investigative and marketing applications for assigned programs, as well as their life cycle management
• Acts as regulatory representative on early and/or late phase clinical studies, ensuring compliant execution of trials
• Strong competency in understanding regulatory requirements and emerging regulatory landscapes associated with US and global regulatory authorities
• Experienced in responding to inquiries from global regulatory authorities as well as the preparation and conduct of meetings with global regulatory authorities
• Assist in the preparation and maintenance of Annual Reports, Development Safety Update Reports (DSURs), Investigator’s Brochures and other documents required for INDs, CTAs, NDAs and other related regulatory development and marketing applications
• Assist in the cataloging and maintenance of regulatory application submissions
• Conduct research and stay up-to-date on regulatory requirements and changes
• Collaborate with cross-functional teams to ensure product compliance throughout the development lifecycle
• Monitor and assess regulatory risks and develop mitigation strategies
• Oversee quality assurance processes to ensure compliance with regulatory standards
• Review SOPs pertaining to Regulatory
• Works strategically with all regulatory functions to develop detailed, actionable submission plans, tracks major submission deliverables, and ensures consistent management submission documents, health authority communications, and all other regulatory information supporting Nurix’s investigational and marketing applications
• Plays an essential part in defining requirements for, implementing, and supporting future systems and tools to be employed by Nurix in the areas of document management, submission content planning, and regulatory information management
• Tracks the status of major deliverables for regulatory submissions (e.g., study reports, summary documents, labeling) along with their dependencies
• Develops and maintains submission plan templates to ensure Nurix regulatory submissions are consistently planned and executed across programs
• Participates in cross-functional process initiatives impacting regulatory submission processes and systems
• Manages consultants and contractors as needed

Experience and Skills:

• Bachelor's degree in life-sciences or related scientific discipline; advanced degree preferred Manager:
• Must have minimum of 8 years in Regulatory affairs strategy
• Strong demonstration of knowledge of drug development, FDA, EMA and ICH guidelines and regulations
• Experience providing hands-on support for planning clinical trial and marketing applications to health authorities including but not limited to FDA, EMA
• Ability to read, analyze and interpret scientific and technical information, as well as regulatory
• Ability to understand and explain detailed regulatory affairs and compliance programs and/or to effectively present information to senior regulatory management, other departments or external
• Ability to comply with changing regulatory
• Proven track record of supporting Regulatory affairs in the planning and execution of major filings and ongoing maintenance of clinical trial and marketing applications
• Strong project management and critical thinking skills
• Experience applying project management techniques and tools (e.g., MS Project, Smartsheet, Excel trackers) to the planning and execution of regulatory submissions
• Excellent organizational and communication skills, both written and verbal
• Ability to work independently as well as part of a team environment
• Positive attitude, energetic and proactive
• Proven ability to manage multiple projects, identify and resolve regulatory issues
• Strong interpersonal skills and the ability to effectively work with others

Nurix Therapeutics, Inc. is committed to protecting and respecting your privacy and personal information, including information collected by Nurix when you apply for a job with Nurix or in the course of your employment with Nurix. By applying for a position at Nurix, you agree to our collection and use of personal information as described in our Privacy Policy (https://www.nurixtx.com/privacy-policy/).

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.

Position

The Senior Manager / Associate Director, Computer Systems Assurance (CSA) is an important technical and operational leader within the Nurix Quality Systems organization, responsible for owning and advancing Nurix's computer systems assurance program. As a virtual drug developer, Nurix operates through a lean internal infrastructure and relies on a curated ecosystem of Software-as-a-Service (SaaS) and cloud-hosted platforms to support GxP-regulated activities across clinical development, quality operations, manufacturing oversight, and regulatory submissions. This role will serve as the primary subject matter expert and program owner for all CSA and computerized system validation (CSV) activities at Nurix.

Reporting to the Vice President / Senior Director, Quality Systems, this individual will establish and maintain Nurix's risk-based CSA framework aligned with current regulatory expectations, including the FDA's 2022 guidance on computer software assurance, GAMP 5 (2nd edition), and applicable 21 CFR Part 11 and Annex 11 requirements. The role requires an individual who combines deep technical knowledge of GxP computerized systems with practical experience in SaaS and cloud-based platform qualification, and who can translate regulatory requirements into pragmatic, fit-for-purpose validation approaches that support a modern, agile biotech environment. This is a high-impact, program-ownership role requiring both strategic vision and hands-on execution. The successful candidate will work closely with Quality, IT, Regulatory Affairs, CMC, Clinical Operations, and external vendors to ensure that all GxP-critical systems are appropriately assessed, validated, and maintained in a compliant state. The individual will champion a risk-based, science-driven approach to CSA across the organization.

Responsibilities

CSA Program Ownership and Strategy

• Own and maintain Nurix's Computer Systems Assurance policy framework, SOPs, and risk-based validation strategy, aligned with FDA CSA guidance (2022), GAMP 5 (2nd edition), 21 CFR Part 11, EU Annex 11, and applicable ICH guidelines.
• Define and implement a fit-for-purpose, risk-tiered approach to system qualification for SaaS and cloud-hosted GxP applications, recognizing the vendor-managed nature of modern software platforms.
• Maintain the GxP system inventory; conduct and document periodic system risk assessments to classify systems and determine appropriate validation scope and rigor.
• Establish and maintain processes for vendor assessment, including review of vendor SOC 2 reports, quality agreements, and audit strategies appropriate for SaaS providers.
• Drive continuous improvement of the CSA program through benchmarking, regulatory intelligence, and adoption of industry best practices.

System Validation and Qualification Execution

• Lead and execute validation activities for GxP SaaS platforms including, but not limited to, eQMS (e.g., Veeva Vault), electronic document management, clinical data management, regulatory information management, and laboratory information systems.
• Author and review validation documentation including Validation Master Plans (VMPs), User Requirements Specifications (URS), Risk Assessments, Vendor Assessments, Validation Protocols (IQ/OQ/PQ), Traceability Matrices, and Validation Summary Reports.
• Manage validation activities associated with system implementations, major configuration changes, upgrades, and periodic re-validation reviews, applying critical thinking to scope validation effort proportionate to system risk and change impact.
• Coordinate validation testing activities with cross-functional stakeholders; ensure test scripts are appropriately designed to demonstrate fitness for intended use.
• Review and approve validation deliverables prepared by internal teams, vendors, or external validation consultants.

21 CFR Part 11 and Data Integrity

• Serve as the internal subject matter expert for 21 CFR Part 11 and EU Annex 11 requirements; assess systems for compliance and provide guidance to cross-functional partners.
• Partner with IT and system owners to ensure electronic records and electronic signature controls are properly implemented and documented in all GxP systems.
• Support data integrity assessments and remediation initiatives; apply ALCOA+ principles to guide compliant system design and use.

Change Management and Periodic Review

• Manage the computerized systems change control process; evaluate proposed changes for validation impact and establish appropriate assessment, testing, and documentation requirements prior to implementation.
• Own and execute the periodic review program for validated GxP systems; assess continued fitness for intended use and compliance with current regulatory expectations.
• Maintain validation status documentation and ensure validation files are audit-ready at all times.

Inspection Readiness and Regulatory Support

• Support preparation for regulatory agency inspections; serve as the CSA subject matter expert during FDA, EMA, and other Health Authority inspections and ensure validation documentation is complete, current, and accessible.
• Contribute to relevant sections of regulatory submissions and respond to agency questions related to computerized systems and data integrity.
• Monitor evolving regulatory guidance and industry standards related to CSA, CSV, data integrity, and cloud-based systems; proactively adapt Nurix's program to reflect current expectations.

Cross-Functional Partnership and Training

• Serve as the primary point of contact and internal consultant for all GxP system owners across Quality, IT, Regulatory Affairs, CMC, and Clinical Operations.
• Develop and deliver CSA training for system owners, end users, and other stakeholders to build organizational capability and awareness.
• Partner with IT and vendor project teams to embed validation requirements early in system selection and implementation processes.

Required Qualifications

• Bachelor's degree in computer science, information systems, life sciences, pharmaceutical sciences, or a related field.
• 7–10+ years of progressive experience in computer systems validation and/or computer systems assurance in a GxP-regulated pharmaceutical, biopharmaceutical, or biotechnology environment.
• Demonstrated expertise in current regulatory requirements for computerized systems, including FDA 21 CFR Part 11, EU Annex 11, FDA CSA guidance (2022), and GAMP 5 (2nd edition).
• Hands-on experience validating SaaS and cloud-hosted GxP platforms; understanding of vendor-managed environments and shared responsibility models.
• Proficiency authoring and reviewing CSA/CSV deliverables: VMPs, URSs, Risk Assessments, IQ/OQ/PQ protocols, traceability matrices, and validation summary reports.
• Strong working knowledge of data integrity principles (ALCOA+) and their application to electronic records management and GxP system design.
• Experience managing system change control and periodic review programs for validated GxP systems.
• Ability to operate as both program owner and individual contributor in a lean, virtual organizational model; comfortable managing validation activities without a large internal support team.
• Excellent written and verbal communication skills; able to translate complex technical and regulatory requirements into practical guidance for diverse stakeholders.
• Strong organizational skills and attention to detail; demonstrated ability to manage multiple concurrent programs and priorities in a fast-paced environment.

Preferred Qualifications

• Experience with eQMS validation (e.g., Veeva Vault) and familiarity with Veeva's Qualified System approach and available supplier documentation.
• Familiarity with clinical development platforms such as electronic data capture (EDC), regulatory information management (RIM), or clinical trial management systems (CTMS) in a validated context.
• Experience supporting FDA, EMA, or equivalent Health Authority inspections as a CSA subject matter expert.
• Exposure to laboratory informatics systems (LIMS, ELN) and their GxP qualification requirements.
• Experience in a virtual or lean biotech environment managing validation activities through external vendors and consultants.
• Working knowledge of cybersecurity frameworks and their intersection with GxP system compliance (e.g., NIST, SOC 2).
• Advanced degree in a relevant scientific, engineering, or regulatory discipline.

Fit with Nurix Culture and Values

• You know the regulations deeply and apply them with judgment, designing validation approaches that are rigorous where it matters and efficient everywhere else. You bring expertise with pragmatism —
• You are comfortable as the go-to expert, driving the CSA program forward proactively rather than waiting for direction, and you take accountability for outcomes. You own the program —
• You build trusted relationships across Quality, IT, and the business, and you understand that a well-designed, compliant systems environment is an enabler of Nurix's mission to develop important medicines for patients. You partner with purpose —

Location: Brisbane, CA - Onsite 

Salary Ranges: Senior Manager, CSA(Quality)      - $170,538 – $193,493                                  
                           Associate Director, CSA(Quality) - $190,269 – $216,360

Nurix Therapeutics, Inc. is committed to protecting and respecting your privacy and personal information, including information collected by Nurix when you apply for a job with Nurix or in the course of your employment with Nurix.  By applying for a position at Nurix, you agree to our collection and use of personal information as described in our Privacy Policy (https://www.nurixtx.com/privacy-policy/). 

Position Title:   Director, Regulatory Affairs (Strategy, Immunology and Inflammation)

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.

Nurix Therapeutics, Inc. is seeking a Director, Regulatory Affairs (Strategy, I&I) to join the Regulatory team.  The successful candidate will be a core member of the Regulatory team and will serve as the global regulatory lead (GRL) for the immunology and inflation therapeutic area. This role will be responsible for developing the global regulatory strategy in collaboration with key internal stakeholders, as well as tactical implementation of that strategy guiding and executing compliant, high quality, nonclinical and clinical submissions and interactions in support of early development, registration and life cycle management activities.  This position works cross-functionally with regulatory affairs and clinical development organizations to facilitate the completion of regulatory filing documentation according to company timelines. It also ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as required. This position is on site in the Brisbane, CA office.

Responsibilities:

• Develop and implement competitive and effective global clinical & nonclinical regulatory strategies for various immunology and inflammation indications and identify potential risks and mitigation strategies associated with proposed strategies
• Work in close collaboration with the SVP, Head of Regulatory Affairs and the development team leader and other cross-functional colleagues, including CROs to deliver sound, efficient development strategies and operational plans
• Represent Regulatory Affairs on assigned cross-functional development teams.
• Lead and manage the development and preparation of high-quality global submissions (including IND, CTAs, NDAs, and MAAs) for early and late-stage programs in collaboration with the regulatory and project teams to support and accelerate clinical development and regulatory approval, as applicable
• Lead communication with global Health Authorities (HA), such as FDA and EMA, including, planning and preparing for formal meetings with regulatory agencies and interpreting HA feedback from these interactions.
• Develops and executes, or oversees global regulatory strategy for long-term planning, including the potential to accommodate expedited development needs
• Anticipate issues and guide cross-functional teams on risk mitigation strategies for any development challenges Provides insight and guidance on the implementation of current regulations and assesses regulatory risk based on precedence
• Ensure adherence to current regulations associated with regulatory activities
• Works strategically with all regulatory functions to develop detailed, actionable submission plans, tracks major submission deliverables, and ensures consistent management submission documents, health authority communications, and all other regulatory information supporting Nurix’s investigational and marketing applications
• Plays an essential part in defining requirements for, implementing, and supporting future systems and tools to be employed by Nurix in the areas of document management, submission content planning, and regulatory information management
• Tracks the status of major deliverables for regulatory submissions (e.g., study reports, summary documents, labeling) along with their dependencies
• Develops and maintains submission plan templates to ensure Nurix regulatory submissions are consistently planned and executed across programs
• Participates in cross-functional process initiatives impacting regulatory submission processes and systems
• Manages consultants and contractors as needed

Requirements

• Bachelor's degree in life-sciences or related scientific discipline; advanced degree preferred Manager:
• Must have minimum of 12 years in Regulatory affairs strategy with significant experience in the immunology and inflammation therapeutic area
• Strong demonstration of knowledge of drug development, FDA, EMA and ICH guidelines and regulations
• Experience providing hands-on support for planning clinical trial and marketing applications to health authorities including but not limited to FDA, EMA
• Proven track record of supporting Regulatory affairs in the planning and execution of major filings and ongoing maintenance of clinical trial and marketing applications
• Strong project management and critical thinking skills
• Experience applying project management techniques and tools (e.g., MS Project, Smartsheet, Excel trackers) to the planning and execution of regulatory submissions
• Excellent organizational and communication skills, both written and verbal
• Ability to work independently as well as part of a team environment
• Positive attitude, energetic and proactive
• Proven ability to manage multiple projects, identify and resolve regulatory issues
• Strong interpersonal skills and the ability to effectively work with others

Salary Range:  220K – 254K plus bonus and equity.

Position Summary:

The Inventory & Cost Accounting Manager, will report to the Senior Director, Revenue and Cost Accounting and play a key role in supporting inventory & cost accounting, as well as assisting with other accounting activities. This role will also be working closely with cross-functional teams throughout the company.

Responsibilities:

Inventory & Cost Accounting:

• Develop a strong business partner relationship with the Supply Chain Manufacturing, Quality, and Process Development functions.
• Prepare and manage cost accounting month-end close journal entries for prepaid manufacturing costs, raw materials, work-in-process and finished goods inventories, and cost of sales while maintaining subledger accounts, reconciliations to ensure compliance with U.S. GAAP.
• Own Inventory and COGS analytics and reporting, including development and maintenance of margin and variance analyses to support business decision-making.
• Support other month end close journal entries and reconciliations as opportunities arise.

Inventory Management & Controls:

• Work directly with contract manufacturing, supply chain, quality, internal & external audit to ensure accurate inventory, existence, valuation, and reporting completeness.
• Assist with SOX efforts in documenting and performing key controls in areas of responsibility.

Systems & Process Improvements:

• Represent inventory & cost accounting related to ERP and system enhancements and process improvements to strengthen data accuracy, automation, and internal controls.
• Continuously evaluate processes and recommend improvements to enhance efficiency and effectiveness.
• Maintain up to date accounting policies and desk procedures to drive operational efficiency.
• Assist with annual audits and quarterly reviews, preparing audit schedules, and other audit requests.
• Maintain a thorough and current understanding of general ledger structure and ensure integrity and accuracy of financial data.
• Potentially provide support for other functions such as revenue accounting, special projects, initiatives, and ad-hoc analyses, as needed.

Qualifications:

• Bachelor’s degree in accounting, finance, or related field.
• 5+ years of relevant experience in biotech and/or pharmaceutical industry.
• Strong working knowledge of system processes, internal controls, GAAP and SOX regulations.
• Strong project management skills with the ability to anticipate events, prioritize assignments, deal with interruptions, and meet deadlines in a fast-paced and growth-oriented environment.
• Strong communication, project management, and organizational skills.
• Strong analytical skills and attention to detail.
• Ability to work independently as well as a collaborative team player.
• Self-starter, proactive, and willing to learn.
• Strong Excel skills.
• Experience working as a contract manufacturing sponsor with inventory & cost accounting in the pharmaceutical industry, a plus.
• Certified Public Accountant (CPA), preferred.
• Experience with NetSuite, preferred.

Position Summary:

The Manager, Accounting, will report to the Associate Director, Accounting and play a key role in supporting clinical and R&D accounting, as well as assisting with G&A accounting activities. This role will work closely with cross-functional teams throughout the company.

Responsibilities:

• Prepare and book journal entries for month-end close, including sub-ledger/ schedule to ledger reconciliations and analysis of reconciling items.
• Prepare R&D and contract manufacturing (CMC) accrual journal entries based on executed contracts and communications with department leads or vendors, maintaining related workbooks and roll-forwards.
• Prepare and manage clinical trial accruals for select CROs and vendors, maintaining accurate accounting workbooks and ensuring proper tracking of expenses.
• Track and maintain monthly accruals and prepaids for assigned vendors and accounts, collaborating with department leads to ensure accurate recording based on contracts and operational needs.
• Track and prepare open Purchase Order accruals based on contracts and services provided, working with PO owners to ensure timeline and accurate month-end accruals.
• Prepare prepaids amortization of assigned accounts and maintain accuracy of subledgers, ensuring that subledgers are maintained accurately and consistently.
• Continuously evaluate processes and recommend improvements to enhance efficiency and effectiveness.
• Maintain a thorough and current understanding of general ledger structure and ensure integrity and accuracy of financial data.
• Assist with SOX 404 efforts in documenting and performing the key controls in areas of responsibility.
• Supporting improvement of accounting policies and procedures to drive operational efficiency.
• Assist with annual audits and quarterly reviews, preparing audit schedules, and other audit requests.
• Provide support for special projects, initiatives, and ad-hoc analyses, as needed, or requested.

Qualifications:

• Bachelor’s degree in accounting, finance, or related field.
• 5+ years of relevant experience in biotech and/or pharmaceutical industry.
• Strong working knowledge of system processes, internal controls, GAAP and SOX regulations.
• Strong project management skills with the ability to anticipate events, prioritize assignments, deal with interruptions, and meet deadlines in a fast-paced and growth-oriented environment.
• Strong communication, project management, and organizational skills.
• Strong analytical skills and attention to detail.
• Ability to work independently as well as a collaborative team player.
• Self-starter, proactive, and willing to learn.
• Strong Excel skills
• Experience with inventory accounting in the pharmaceutical industry, a plus
• Experience with CRO/CMC accrual software, a plus.
• Certified Public Accountant (CPA), preferred.
• Experience with NetSuite, preferred.

Position Summary:

The Associate Director, GxP Systems will report to the Sr. Director, Commercialization Systems and will be responsible for leading the implementation, validation, and support of GxP-regulated systems to enable Quality Assurance, Regulatory, Clinical, and Process Development & Manufacturing (PD&M) in a commercial biotech environment. This role will play a pivotal part in supporting regulatory, compliance, and for commercialization. Working with Quality Assurance, Medical Affairs, Regulatory Affairs, Clinical Operations, and PD&M functions to ensure systems are fit-for-purpose, validated and aligned with evolving business requirements.

Responsibilities:

• Serve as the System Owner and hands-on administrator for GxP systems (e.g., TraceLink, Lorenz DocuBridge, Egnyte Life Sciences, ZenQMS, Global Vision, Veeva), overseeing system lifecycle, performance, and compliance
• Participate in system implementation activities, including vendor selection, requirements gathering, testing, and deployment to ensure alignment with business and regulatory needs
• Provide oversight and direction for Computer System Validation (CSV) activities and validation documentation, partnering with the Validation Engineer to ensure regulatory compliance and audit readiness
• Own and lead Change Control processes for all GxP systems, including impact assessments, risk evaluations, documentation, coordination of testing, and release management
• Perform system administration activities, including user access provisioning, role management, periodic access reviews, and audit trail monitoring
• Oversee system maintenance, enhancements, and issue resolution (e.g., upgrades, patches, changes), ensuring appropriate validation impact assessments, documentation updates, and minimal business disruption
• Collaborate with IT and vendors to support integration, system performance optimization, and resolution of technical issues
• Develop and maintain system-related documentation, including SOPs, Systems Inventory, administrative procedures, and work instructions in collaboration with Quality Assurance and business stakeholders
• Provide SME support during FDA audits and inspections, including preparation, documentation review, and representation of system controls and validation status
• Drive continuous improvement by identifying gaps, inefficiencies, and opportunities for system scalability and automation
• Translate business requirements into effective system solutions, acting as a key liaison between business stakeholders and technical teams
• Manage project timelines, risks, and deliverables to ensure successful and compliant execution of system initiatives

Qualifications:

• Bachelor’s degree in Life Sciences, Information Systems, Computer Science, Engineering, or a related field; advanced degree preferred
• 10-12 years of hands-on experience with GxP systems in Life Sciences, including system administration, validation oversight, and operational support
• Proven experience implementing and validating systems such as eQMS, TraceLink, LMS, Validated Documents and Data storage solutions (such as Box for GxP or Egnyte Life Sciences), or ERP systems (e.g., NetSuite, Oracle, SAP) in a GxP-regulated environment
• Strong understanding of CSV, data integrity, Part 11 compliance, and regulatory expectations (FDA, EMA, ICH)
• Experience partnering with validation/CSV resources while maintaining accountability for system compliance and validation outcomes
• Proven experience owning and managing Change Control processes for GxP systems
• Experience supporting pre-commercial biotech organizations transitioning to commercialization
• Ability to balance strategic oversight with hands-on system administration and operational responsibilities
• Strong cross-functional collaboration skills across IT, QA, Regulatory, and Technical Operations
• Experience managing vendors and implementation partners
• Excellent troubleshooting, analytical, and problem-solving skills
• Strong communication skills with the ability to translate technical concepts into business terms and influence stakeholders

Position Summary:

The Executive Assistant role will report to the Chief Business Officer (CBO) and will act as a partner to executives across the office of the CBO, including Corporate Communications, Portfolio & Program Management, and Business Development & Alliance Management functions. This role is ideal for someone who thrives in fast-moving environments, brings structure to ambiguity, and can seamlessly shift between executive support and operational coordination. This role enables leadership to stay focused on strategy and growth by ensuring administrative priorities and cross-functional initiatives continue moving forward despite ambiguity and shifting priorities.

Responsibilities

Executive & Leadership Support

• Manage complex executive calendars, travel, expense reporting, and meeting prioritization.
• Prepare briefing notes and key materials for internal and external meetings.
• Coordinate meetings and track action items.
• Help track department budgets.

Project & Operational Coordination

• Support portfolio/program management activities and cross-functional coordination.
• Track priorities, risks, and dependencies across initiatives.

Communications & Corporate Initiatives

• Support internal communication platforms and staff company-wide events.
• Oversee scheduling of corporate-wide events and event management.
• Manage contracts and SOWS with external consultants and speakers.
• Coordinate with other EAs on internal events.

Business Development Support

• Coordinate materials and logistics for business development meetings and partner interactions.
• Assist with coordination of external conferences, partner meetings, and other business development engagements.
• Support diligence processes by organizing materials, timelines, and internal coordination.
• Assist in tracking BD opportunities and maintaining internal trackers.

Qualifications:

• BA/BS degree with 2-3+ years of experience supporting senior executives or leading operational coordination in biotech, consulting, or high-growth environments.
• Experience supporting business development, strategy, or corporate functions preferred.
• Strong organizational skills and comfort managing multiple priorities that change quickly.
• Clear, concise communicator who can work effectively across functions and levels.
• Proactive, resourceful, and comfortable operating with limited direction.
• Demonstrates a high level of discretion, ownership, and accountability when handling sensitive information and supporting executive-level priorities.
• Highly proficient with productivity and collaboration tools including Microsoft Office (Excel, PowerPoint), Slack, Box, and modern AI productivity tools (e.g., ChatGPT, Claude).

Position Summary:

The Senior Manager, Quality Assurance (QA), will report to the Director, QA Drug Substance and is primarily responsible for QA function for Cell Bank and Drug Substance (DS). The position is responsible for collaborating with cross-functional teams and external partners to ensure both clinical and commercial Drug Substances meet regulatory requirements and internal Vera standards.

Responsibilities:

• Support the oversight of the quality and compliance, primarily cell bank and biologics DS manufacturing.
• Support implementation of strategies and tactics to promote and maintain GxP compliance.
• Provide quality support on tech transfers.
• Liaise with CMO Quality partners to communicate QA policy and procedures.
• Collaborate with contract manufacturers and internal stakeholders to address deviations/ investigations and compliance issues.
• Responsible for material disposition of cell banks, commercial and clinical DS.
• Review executed batch records and associated documentation for material disposition.
• Review and approve GMP documentation such as master batch records, deviations, change controls, specifications, and various other protocol and reports to support GMP production.
• Provide quality support for validations including process validation, shipping validation, cleaning validation, etc.
• Provides support during both internal and regulatory agency audits as required.
• Perform Person-in-Plant duties, as required.
• Participate in Material Review Board as required.
• Helps define and implement appropriate quality standards/specification, methods, systems, and metrics for clinical and commercial quality operations.
• Act as the Quality representative on assigned product teams to advocate compliance and quality assurance.
• Participate in Quality Agreements negotiation with external partners.
• Support product lifecycle and continued process verification.
• Availability for 5-15% travel, both domestically and internationally.

Qualifications: 

• Bachelor’s degree with 10+ years of experience in biomedical engineering, chemical engineering, pharmaceutical sciences, or a related field or a Master’s degree with 7+ years of experience in biomedical engineering, chemical engineering, pharmaceutical sciences, or a related field.
• Minimum 6+ years of experience in a GMP Quality, Compliance, and/or Regulatory setting.
• Minimum 6+ years in a GMP QA role, and preferably direct work experience in either Manufacturing or QC, as well.
• Excellent written and verbal communication skills, including demonstrated ability to effectively communicate in a project team environment, within department, among functional groups and among external collaborators.
• Innovative skills with problem solving and peer influence.
• In-depth knowledge of FDA, ISO, EMA, GMP and ICH quality systems and regulatory requirements.
• Experience of working with external partners and biologics DS manufacturing.
• Experience working with Cell Bank is a plus.
• Experience with process validation is a plus.
• Strong attention to detail is a must.
• Excellent interpersonal, written and oral communication skills.
• Outstanding organizational skills.
• Ability to operate in a fast-paced, multi-disciplinary industrial environment.
• Capable and comfortable with normally receiving no instructions on routine work and general instructions on new assignments.

Position Summary:

The Vice President, Regulatory Affairs will be responsible for the development and execution of the company’s Regulatory strategy and report into the Senior Vice President, Regulatory and Quality.  This critical hire will provide input, prioritize, implement, monitor, and communicate Vera’s Regulatory strategy and programs.  As part of the Quality and Regulatory leadership team, you will establish and translate Vera’s Regulatory strategy into operational policies, processes, procedures, and training to meet global regulatory, medical/health, and legislative standards.  This role requires experience, knowledge, and leadership credibility to be effective across Vera in multiple capacities, thereby ensuring compliance with Regulatory standards and corporate-wide commitment to Quality principles and Vera values.

Responsibilities:

Additional representative responsibilities will include, but not necessarily be limited to, the following:

• In this highly visible role, the successful candidate will develop and lead integrated global regulatory strategies (US, EU, and key ex‑US markets) for all pipeline programs, aligning with overall corporate and clinical development goals.
• Serve as a primary regulatory strategist providing clear assessments of regulatory options, risks, and timelines to inform portfolio and investment decisions.
• Oversee planning, authoring, review, and submission of regulatory dossiers including pre‑IND/IMPD packages, INDs/CTAs, IBs, pediatric plans, orphan/expedited program requests, DSURs/PSURs, NDAs/BLAs/MAAs, and post‑approval supplements/variations.
• Lead or directly oversee global health authority interactions (e.g., FDA, EMA, PMDA and key national agencies), including scientific advice/protocol assistance, Type B/C meetings, pre-submission and advisory committee preparations; ensure high‑quality briefing packages and robust meeting follow‑up.
• Partner closely with cross-functional teams to ensure clinical trial designs, endpoints, and statistical plans are aligned with regulatory expectations and support future registration.
• Oversee global CMC regulatory strategies, including module 3/quality sections, comparability plans, and lifecycle management; ensure alignment with GxP and ICH requirements.
• Ensure timely, accurate maintenance of all active INDs/CTAs and marketing authorizations, including safety reports, annual reports, labeling updates, and other commitments.
• Build, lead, and mentor a high‑performing regulatory team effectively leveraging external consultants, CROs, and vendors for eCTD publishing and ex‑US submissions.
• Establish and continuously improve phase‑appropriate regulatory processes, standards, and governance (e.g., submission planning, HA interaction tracking, labeling governance) suitable for a lean organization.
• Stay current on evolving global regulatory requirements, guidance, and precedent, and proactively incorporate learnings into program strategies and company policies.
• Support business development activities by contributing regulatory due diligence, risk/benefit assessments, and integration planning for potential partnerships, in‑licensing, and acquisitions.
• Represent Regulatory Affairs on cross‑functional governance bodies and, as needed, with partners, and external stakeholders.

Qualifications:

• Advanced degree in life sciences or related discipline (e.g., PhD, PharmD, MD, or MS); equivalent experience may be considered.
• 15+ years of increasing responsibility in biopharmaceutical regulatory affairs, including substantial experience in small or mid‑size biotech environments.
• Proven track record of leading major global submissions (IND/CTA and NDA/BLA/MAA or equivalent) through acceptance and, ideally, approval.
• Demonstrated experience interacting directly with FDA, EMA and other global health authorities, including leading meetings and negotiations on complex issues.
• Strong understanding of global regulatory frameworks (ICH, FDA, EMA and other regional requirements) across early development, registration, and post‑approval lifecycle management.
• Experience overseeing or partnering with CMC, regulatory operations/electronic submissions (eCTD), and safety/periodic reporting activities.
• Demonstrated ability to build, lead, and develop teams, and to work effectively as both a hands‑on individual contributor and strategic leader in a lean, fast‑paced biotech setting.
• Excellent written and verbal communication skills, with the ability to convey complex regulatory concepts clearly to both technical and non‑technical audiences, including senior leadership and external partners.
• High degree of integrity, sound judgment, and a pragmatic, solutions‑oriented mindset with strong organizational and project management skills.

About us (Woolpert)

Woolpert is a global leader in Architecture, Engineering and Geospatial (AEG), with a longstanding and expanding presence across Australia. Building on our rich heritage as AAM, we deliver cutting edge solutions in aerial mapping, surveying, GIS, and digital transformation for major resources, infrastructure, and environmental projects – standing and expanding presence across Australia. Building on our rich heritage as AAM, we deliver cutting‑edge solutions in aerial mapping, surveying, GIS, and digital transformation for major resources, infrastructure, and environmental projects.

Our culture—known as the Woolpack—is built on innovation, inclusion, and ownership. Through our Principal Program, every team member could become a company owner and share in our collective success. Woolpert has proudly been certified as a Great Place to Work® for the ninth time.

The opportunity with us as the Support Consultant

Woolpert’s Digital Delivery Team is looking for a Support Consultant! You may choose to be based in our Brisbane, Perth, Melbourne, Sydney or Adelaide office for this hybrid role.

Reporting to the Project & Support Manager, the role gives you the opportunity work with customers to resolve technical support cases raised through our geospatial help desk.

As a Support Consultant at Woolpert, you will:

• Be a trusted point of contact for our customers, resolve first and second level software support requests with confidence and care.
• Manage customer phone calls and e-mails through our Helpdesk system and liaising with internal staff to triage and resolve technical support issues.
• Investigate, troubleshoot, and resolve software issues across our geospatial platforms, including VertiGIS Geocortex and Esri ArcGIS.
• Providing regular reporting on support KPIs.

We’re looking for someone who has:

• Tertiary qualifications or equivalent in IT, computer science, software engineering or geomatics.
• Hands‑on experience supporting Microsoft‑based environments, including Windows OS, Active Directory, and common desktop or server applications.
• A solid understanding of core networking concepts such as IP addressing, DNS, firewalls, and basic diagnostics.
• Experience identifying and diagnosing issues in web‑based applications, including understanding how HTTP/HTTPS requests, responses, and authentication flows work.
• Excellent communication skills and the ability to collaborate effectively with customers and internal stakeholders at all levels.

The team does consider the below desirable experience, so do let us know if you have any of the following!

• Exposure to reading or writing code in any language, with an understanding of logic, variables, and error handling.
• Experience with scripting or automation (e.g. batch files or PowerShell) to support repeatable tasks or diagnostics.
• Familiarity with GIS and/or CAD applications, particularly Esri ArcGIS and VertiGIS, or a strong interest in developing skills in spatial technologies.
• Knowledge of corporate or cloud networking environments, including on‑premises to cloud connectivity and common security controls.

Desirable qualifications are:

• Current Driver’s licence 
• Current passport 

Woolpert Benefits

• Want to earn long-term rewards that reflect your impact? Woolpert’s Principal Program gives employees the opportunity to become stakeholders in the company and benefit directly from its growth and success.
• Want surety for your income? Woolpert employees benefit from automatic Salary Continuance Insurance provided by the company.
• Want to make the most of your salary? Woolpert offers novated leasing and salary sacrifice options to help you get more value from your income.
• Thinking of advancing your studies? Woolpack members wanting to continue their formal education with role related courses have access to reimbursements and study leave options to assist with their studies.
• Need flexibility with where you work? Subject to operational requirements Woolpert offer flexible work arrangements.
• Looking after your wellbeing? Woolpert employees and their immediate family members have access to our confidential Employee Assistance Program, along with our discounted voluntary corporate health insurance through Bupa.

#LI-Hybrid #LI-PM1

We value diversity and inclusion at Woolpert and are committed to creating a workplace that reflects the diversity of the communities we serve. We welcome applications from First Nations peoples.

As this is a full-time role, this role requires individuals with Full Working Rights in Australia. Successful candidate is required to go through a National Police Background Check (covered by Woolpert), and only shortlisted candidates will be contacted.

If you believe you might be a good fit and would like to join our Woolpack, click on the APPLY NOW button to submit your application. If you don’t meet all the preferred experience for this position, we encourage you to still apply!

CSQ327R30

At Databricks, we are on a mission to empower our customers to solve the world's toughest data problems by utilizing the the Databricks Data Intelligence Platform. As a Delivery Solutions Architect (DSA), you will play an important role during this journey. You will collaborate with our sales and field engineering teams to accelerate the adoption and growth of the Databricks platform in your customers. You will also help ensure customer success by increasing focus and technical accountability to our most complex customers who need guidance to accelerate usage on Databricks workloads that they have already selected, helping them maximise the value they get of our platform and the return on investment.

This is a hybrid technical and commercial role. It is commercial in the sense that you will drive growth in your assigned customers and use cases through leading your customers' stakeholders, building executive relationships, orchestration of other focused/specialized teams within Databricks, and creating and driving plans and strategies for Databricks colleagues to build upon. This is in parallel to being technical, with expectations being that you become the post-sale technical lead across all Databricks products. This requires you to use your skills and technical credibility to engage and communicate at all levels with an organisation. You will report directly to a DSA Manager within the Field Engineering organization. 

The impact you will have:

• Engage with Solutions Architects to understand the full use case demand plan for prioritised customers
• Lead the post-technical win technical account strategy and execution plan for the majority of Databricks use cases within our most strategic accounts
• Be the accountable technical leader assigned to specific use cases and customer(s) across multiple selling teams and internal stakeholders, creating certainty from uncertainty and driving onboarding, enablement, success, go-live and healthy consumption of the workloads where the customer has made the decision to consume Databricks
• Be the first contact for any technical issues or questions related to production/go live status of agreed upon use cases within an account, oftentimes services multiple use cases within the largest and most complex organizations
• Leverage both Shared Services, User Education, Onboarding/Technical Services and Support resources, along with escalating to expert level technical experts to build the right tasks that are beyond your scope of activities or expertise
• Create, own and execute a point-of-view as to how key use cases can be accelerated into production, coordinating with Professional Services (PS) resources on the delivery of PS Engagement proposals
• Navigate Databricks Product and Engineering teams for new product Innovations, private previews and upgrade needs
• Develop an execution plan that covers all activities of all customer-facing technical roles and teams to cover the below work streams:
• Main use cases moving from ‘win’ to production
• Enablement / user growth plan
• Product adoption (strategy and activities to increase adoption of Databricks’ Lakehouse vision)
• Organic needs for current investment (e.g. cloud cost control, tuning & optimization)
• Executive and operational governance
• Provide internal and external updates - KPI reporting on the status of usage and customer health, covering investment status, important risks, product adoption and use case progression - to your Technical GM

What we look for:

• 5+ years of experience where you have been accountable for technical project / program delivery within the domain of Data and AI and where you can contribute to technical debate and design choices with customers
• Programming experience in Python, SQL or Scala 
• Experience in a customer-facing pre-sales, technical architecture, customer success, or consulting role
• Understanding of solution architecture related distributed data systems
• Understanding of how to attribute business value and outcomes to specific project deliverables
• Technical program, or project management including account, stakeholder and resource management accountability
• Experience resolving complex and important escalation with senior customer executives
• Experience conducting open-ended discovery workshops,  creating strategic roadmaps, conducting business analysis and managing delivery of complex programmes/projects
• Track record of overachievement against quota, Goals or similar objective targets
• Bachelor's degree in Computer Science, Information Systems, Engineering, or equivalent experience through work experience
• Can travel up to 30% when needed

As part of the Fever Originals team, you will use data and insights to create one-of-a-kind events and experiences that allow people to have unforgettable moments. 

ABOUT THE ROLE

We are looking for an experienced, passionate, and critical-thinking event producer who will support our Executive Producer and Project Manager in all aspects of production ensuring that high-quality experiences are delivered. This person will serve as the point of contact on the production side of all projects, being responsible for the third parties involved in the execution, development, and production of the creative deliverables.

To support the development of new events, the Producer will research and periodically support the implementation of new production formats, technologies, and solutions that could enhance Fever’s experiences.

This role requires flexibility, creativity, attention to detail, and the ability to meet deadlines while staying within budget. The ideal candidate has a proven track record in live event production and experiential marketing.

Candidates should be passionate about delivering results and producing fun and entertaining experiences for all walks of the public. Strong communication skills are critical to success in this role. The right candidate will be a self-starter and have strong interpersonal and project management skills.

Employees are expected to be in the office Monday to Thursday with possibility to work from home on Fridays.

This is a temporary maternity cover contract (12 months).

You will:

• Manage all aspects of events production, including pre-production logistics planning, vendor selection, hiring, onsite execution, as well as post-event wrap-up
• Create production timelines and ensure that teams are keeping to schedule
• Communicate and collaborate with Project Managers and on-site teams to drive alignment and execution of concerts
• Optimize production costs and processes whenever possible
• Manage thorough follow-up of third parties' quotes, invoices and P&L updates
• Secure proper event permits and meet insurance requirements
• Venue research and booking
• Secure proper event permits and meet insurance requirements
• Handle administrative duties including expense reports, invoicing, and working with the legal department on contracts 
• Domestic and international travel and work across time zones may be required 

QUALIFICATIONS

You have a track record of successfully produced events with strong data analysis, oral and written communication skills. You thrive in a fast-paced environment and pride yourself on your flexible, detailed, analytical mindset.

The role requires a mix of business development and operational experience. Candidates need to be passionate about the entertainment/events industry. You will have to be comfortable delivering results in an ambiguous environment, being exceptionally detail-orientated while looking around corners, and thinking bigger about how we create a compelling experience. 

• 4+ years of experience in the event production industry
• Native/Fluent level of English. Other languages a plus.
• Ability to manage multiple projects at any given time and pull together multiple aspects of an event in an organized and efficient way
• Have an innovative mindset to identify cutting edge solutions in the production space
• Have a strong network of vendors and venues 
• Understanding of technical production requirements 
• Basic knowledge of fabrication processes  and familiarity with permitting processes  
• Huge appetite for learning and the ability to pick up new skills quickly
• You'll be solution-focused, identifying problem areas and then creating plans to find resolutions 
• Have strong communication skills and a proven track record of building positive working relationships
• Curious and keen to push boundaries and try new concepts
• Able to communicate with partners, brands, agencies, and talent on efforts
• Ability to think strategically when faced with an events partnership brief or with our proprietary data on what events work
• Collaborative and willing to get hands dirty
• Knowledge of promotional tools such as Facebook and Instagram is a plus

You can expect to join a group of diverse, hardworking team players, where a cultural fit is someone willing to stay humble and learn and can work nimbly. We welcome applications with unusual backgrounds with the expectation that the applicant will have acquired hard or soft skills and maturity throughout their experiences.

BENEFITS

• Attractive compensation package and the potential to earn a significant bonus for top performance.
• Opportunity to have a real impact in a high-growth global category leader
• 40% discount on all Fever events and experiences
• Private health insurance
• Work in the heart of the city, with possible travel across our markets
• Responsibility from day one and professional and personal growth
• Great work environment with a young, international team of talented people to work with!

Our hiring process

• A 30 min video call with one of our Talent Acquisition Managers, to better understand your career plan, assess cultural fit, and answer any questions you may have
• A 60 min online test with three topics: logic, analytics, and written understanding
• A 30 min interview with your future manager
• A 45 min video call with your future manager, including questions about your profile.

On average our process lasts 20 working days and offers usually follow within a week.

#LI-Remote

About this opportunity:

We are looking for an experienced Senior Manager, IT Infrastructure to lead the team through the architecture, design, and implementation of infrastructure technologies that will be critical in providing the technology platform Freenome needs to scale its business. This role will involve new technology implementations and managing the support of current infrastructure including working with supporting vendors. 

The Senior Manager, IT infrastructure will have a deep and broad knowledge of networking, virtualization, server, storage, and operating system technologies, both on-premise as well as in the GCP cloud. This position will work closely with the Information Security team to ensure a compliant and secure infrastructure environment. 

The role reports to the Director, IT. This role will be a Hybrid role.

What you’ll do:

• Leads team of network engineers, system administrators, lab system administrators to support Freenome infrastructure (On prem, Labs and GCP).
• Problem Solving, collaboration, solid comprehension of cloud, virtualization, storage, networking, software and hardware, strategic planning, leadership, mentorship, creating and giving presentations.
• Identify, create, and apply process improvement to increase product and service quality to achieve business objectives.
• Contributes to defining the department's long-term strategy and goals.
• Collaborate with the Help desk and Business Application team to define and implement the infrastructure needed for day to day operations.
• Ensures data security and disaster recovery protocols are in place. Ensuring compliance with regulatory requirements.
• Develops and creates standardized processes and procedures to guide documentation and knowledge base development for IT infrastructure operations support.
• Develops and supports standards for enterprise-wide use of resources. Recommends enterprise level strategies and goals for infrastructure hardware and software procurement and deployment. Writes detailed scopes of work for staff projects.
• Plan, communicate, and deploy changes to IT infrastructure per standard change management process and scheduled maintenance windows. Coordinate IT change and maintenance activities with business stakeholders.
• Maintains IT infrastructure and network diagrams, asset/equipment inventory and IT change/incident logs.
• Supports IT audits and conduct IT systems/network vulnerability scanning, patching and hardening.
• Manage external vendor relationships. 

Must haves:

• 7+ years’ experience in a technology leadership/management role.
• Strong management and technical skills, most notably architect-level skills in virtualization, systems administration, scalable upgrade and migration strategies, networking, and storage. Possess the technical expertise with virtualization and network infrastructure technologies such as VMware vSphere, LAN and WAN.
• 5+ years of experience managing or maintaining enterprise IT infrastructure (Network, IaaS, PaaS, and/or Security).
• Experience in a continuous improvement environment with a track record of achieving significant continual development.
• Strong project management, problem solving, organizational, relationship, communication, and negotiation skills (oral and written) are required.
• 7+ years of experience with Windows 10/11, Windows server, DAS/NAS/SAN, Google workspace, and GCP.
• Strong knowledge of security access controls, policies, groups, rights, and permissions.
• Familiarity with IT GRC (BCDR, ITSM/ITIL, SOX, ISO, PCI, HIPAA, GMP, GDPR, FDA 21 CFR Part 11).
• Ability to document and explain complex technical solutions to management and other non-technical staff.
• Strong customer service and time management skills, with the ability to work effectively in a dynamic, and fast-paced environment.
• Flexibility to work weekends and after hours for IT projects/maintenance (on occasion).

Nice to haves:

• Bachelor's degree in MIS/CIS, Computer Science or equivalent professional experience.
• Industry certifications such as ITIL, CCNA, MCITP, MCSA, MCSE, VCP, Cloud+, Security+ preferred.
• Experience with GMP systems and IT systems change management process.
• Experience with Juniper, Meraki, Netapp, VmWare, and Google workspace.

Benefits and additional information:

The US target range of our base salary for new hires is $180,975 - $232,575. You will also be eligible to receive equity, cash bonuses, and a full range of medical, financial, and other benefits depending on the position offered.  Please note that individual total compensation for this position will be determined at the Company’s sole discretion and may vary based on several factors, including but not limited to, location, skill level, years and depth of relevant experience, and education. We invite you to check out our career page @ freenome.com/job-openings/ for additional company information.  

Freenome is proud to be an equal-opportunity employer, and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Applicants have rights under Federal Employment Laws.  

• Family & Medical Leave Act (FMLA)
• Equal Employment Opportunity (EEO)
• Employee Polygraph Protection Act (EPPA)

#LI-HYBRID