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/). 

Senior Manager, Quality Operations

Nurix Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation therapeutics. Leveraging our proprietary DELigase platform, we design small molecules that harness the body’s own protein disposal system to selectively eliminate disease-causing proteins. Our pipeline spans oncology and immune-mediated diseases, and our team is united by a commitment to scientific excellence and meaningful impact for patients.

We are a team of scientists, innovators, and problem-solvers committed to improving patient lives. We value integrity in everything we do — from the bench to the boardroom — and we foster an environment where every voice is heard and every contribution matters.

Position

The Senior Manager, Quality Operations is an important operational and technical contributor within the Nurix Quality organization, responsible for supporting the quality operations and GMP compliance activities that underpin Nurix’s clinical development programs. This role will partner closely with CMC teams, CDMOs, and internal stakeholders to ensure quality oversight across drug manufacturing, laboratory operations, auditing, and inspection readiness.  Reporting to the Senior Director, Quality, the Senior Manager will execute essential quality systems activities including deviation management, change control, CAPA, batch record review, and audit support. This individual will demonstrate strong independent judgment, meticulous attention to detail, and the ability to collaborate effectively across functions in a dynamic, early to late clinical-stage environment where quality and program timelines are closely intertwined

Responsibilities

Drug Manufacturing Quality Operations

• Execute and support quality systems operations for clinical development, including document management, deviation management, change control, CAPA, training, and validation activities.
• Provide day-to-day quality oversight of CDMOs and contract laboratory operations, including review and approval of deviations, OOS/OOT investigations, batch records, specifications, sampling and testing plans, analytical methods, and lot disposition decisions.
• Review and approve development, process transfer, and validation protocols and reports; verify process data in support of CMC regulatory submissions (INDs and NDAs).
• Approve production-related activities including master batch records, change controls, stability study protocols and reports, and certificate of analysis reviews.
• Participate in CMO selection, commissioning, qualification, and certification activities, support negotiation and maintenance of quality agreements with contract manufacturing partners.
• Support risk management assessments of suppliers and manufacturing processes.
• Manage and file quality documents in the electronic document management system; ensure timely completion of document lifecycle activities in compliance with internal procedures.

Quality Auditing

• Support domestic and international GMP audits of contract manufacturers and laboratory service providers; collaborate cross-functionally with internal stakeholders to assess compliance with applicable regulations and Nurix SOPs.
• Support internal quality audits to evaluate Nurix’s GMP compliance; document findings, prepare audit reports, and track corrective action commitments.
• Communicate audit findings clearly to auditees and management; partner with auditees to develop thorough root cause analyses and CAPA plans. 

Inspection Readiness

• Support preparation and coordination for regulatory agency inspections of Nurix and contract manufacturing partners, including pre-approval inspections (PAIs).
• Assist with inspection logistics, document preparation, back-room operations, and response coordination during Health Authority GMP inspections.
• Contribute to ongoing inspection readiness programs, including gap assessments, mock inspection activities, and training.

Qualifications

• Bachelor’s degree in chemistry, pharmaceutical sciences, life sciences, or a related field.
• 7+ years of progressive Quality Assurance experience in clinical or commercial pharmaceutical or biopharmaceutical operations, with demonstrated hands-on responsibility for GMP quality systems
• Strong working knowledge of GMP regulations and their practical application in CMC development and CDMO management (21 CFR Parts 210/211, ICH Q7, Q8, Q9, Q10, EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines).
• Hands-on experience with deviation investigations, CAPA management, change control processes, and batch record review and approval.
• Ability to travel to CDMO and laboratory sites domestically and internationally, as needed.
• Experience supporting or conducting GMP audits of contract manufacturers and laboratory service providers; ability to write clear, comprehensive audit reports.
• Familiarity with regulatory submission processes and experience reviewing or contributing to CMC sections of regulatory filings.
• Proficiency with eQMS platforms, electronic document management systems, and Microsoft Office suite.
• Strong attention to detail and organizational skills; demonstrated ability to manage multiple concurrent priorities and deliver against deadlines.
• Excellent written and verbal communication skills; able to work effectively across functions and with external manufacturing partners.
• Ability to travel to CDMO and laboratory sites domestically and internationally, as needed.

Salary Range:  $137,859 - $155,758 plus bonus & equity.

Location:  Brisbane, CA – Onsite

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/). 

Senior Director, Quality Assurance 

Nurix Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation therapeutics. Leveraging our proprietary DELigase platform, we design small molecules that harness the body's own protein disposal system to selectively eliminate disease-causing proteins. Our pipeline spans oncology and immune-mediated diseases, and our team is united by a commitment to scientific excellence and meaningful impact for patients.We are a team of scientists, innovators, and problem-solvers committed to improving patient lives. We value integrity in everything we do — from the bench to the boardroom — and we foster an environment where every voice is heard and every contribution matters.

Position

The Senior Director, Quality Assurance is a leadership role within the Nurix Quality organization, responsible for providing strategic and operational oversight of GMP/GLP quality assurance activities supporting small molecule CMC development. This leader will serve as the primary quality interface with external contract development and manufacturing organizations (CDMOs), ensuring the quality, compliance, and timely supply of clinical materials across Nurix’s pipeline programs.

Reporting to the Senior Vice President, Quality, the Senior Director will apply sound independent judgment to drive timely identification, investigation, and resolution of quality events, while building a culture of continuous improvement and cross-functional collaboration. This individual will be accountable for regulatory inspection readiness, quality oversight of external manufacturing and laboratory partners, and for contributing to the evolution of Nurix’s quality systems as the company advances through late-stage clinical development and toward commercialization.

This is a high-visibility role with direct accountability across Quality, CMC, Regulatory Affairs, and external manufacturing partners. The Senior Director will lead and mentor a team of Quality Assurance professionals and will be expected to operate both strategically and hands-on as needed in a dynamic, early to late clinical-stage environment.

Responsibilities

• Provide strategic quality leadership for CMC development programs, ensuring GMP/GLP compliance with FDA, Ex-US regulatory authorities, and ICH guidelines across drug substance and drug product development.
• Oversee quality operations at CDMOs and contract laboratories, including review and approval of deviations, investigations, batch records, lot disposition, technical protocols and reports, methods, and specifications.
• Lead and develop a team of Quality Assurance professionals; establish clear performance expectations, provide mentorship, and build organizational capability to support pipeline advancement and commercialization readiness.
• Drive timely identification, investigation, and resolution of quality events and deviations; oversee CAPA execution and effectiveness verification to prevent recurrence.
• Manage the change control process, ensuring appropriate capture of changes impacting internal procedures and regulatory filings; communicate and escalate issues with broad cross-functional impact.
• Lead regulatory inspection readiness activities; serve as a senior quality representative during FDA, EMA, and other agency inspections and manage observation responses.
• Contribute to CMC sections of regulatory filings (INDs, NDAs/BLAs) and support responses to agency questions in partnership with Regulatory Affairs.
• Partner with CMC and Regulatory Affairs teams to align quality deliverables with pipeline milestones and program timelines.
• Champion continuous improvement of quality assurance processes and procedures, leveraging data, metrics, AI tools, and cross-industry best practices.
• Support implementation and optimization of electronic quality management systems (eQMS) platform; contribute to system improvement initiatives.
• Maintain current knowledge of evolving regulatory expectations and industry standards; translate requirements into practical operational guidance for the organization.

Qualifications 

• Bachelor’s degree in chemistry, pharmaceutical sciences, life sciences, or a related field.
• 12+ years of progressive Quality Assurance experience in the pharmaceutical or biopharmaceutical industry, with experience in formal leadership role.
• Deep technical expertise in GMP requirements for small molecule drug substances and drug products across clinical development stages.
• Demonstrated experience managing CDMO relationships and overseeing quality operations at contract manufacturing and laboratory organizations.
• Thorough knowledge of FDA regulations (21 CFR Parts 210/211) and ICH guidelines (Q7, Q8, Q9, Q10, Q11), and EudraLex - Volume 4 - Good Manufacturing Practice (GMP) and their practical application to CMC development.
• Proven track record managing quality events, deviations, CAPA programs, and change control in a clinical or commercial pharmaceutical setting.
• Experience supporting or leading regulatory agency inspections (FDA, EMA, or equivalent); experience as lead QA representative during pre-approval inspections preferred.
• Demonstrated ability to lead, develop, and motivate Quality Assurance teams in a fast-paced, ambiguous, clinical-stage environment.
• Excellent project management skills with the ability to manage multiple high-priority deliverables simultaneously.
• Strong verbal and written communication skills; able to present complex quality and compliance topics clearly to diverse stakeholders, including executive leadership.
• Willingness to travel to CDMO and laboratory sites domestically and internationally, as needed.

Preferred Qualifications 

• Experience in a clinical-stage biotech environment scaling quality operations through late-stage development and toward commercialization.
• Experience with electronic QMS platforms (e.g., Veeva Vault) and document management systems.
• Expertise in both development-phase and pre-commercial-phase quality assurance standards and expectations.

Fit with Nurix Culture and Values 

• You lead with integrity and set the standard — you bring the same rigor and accountability to quality systems that our scientists bring to the bench
• You are a builder who thrives in ambiguity, energized by the opportunity to shape something meaningful from the ground up in a high-growth environment
• You invest in people — you know that sustainable quality outcomes depend on capable, engaged teams, and you take developing others as seriously as you take system compliance

Salary Range: $238,155 - $270,990 plus bonus and equity 

Location:  Brisbane, CA – Onsite

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/). 

Applicants must be legally authorized to work for any employer in the United States.

Note to Employment Agencies: Please do not forward any agency resumes. Nurix will not be responsible for fees related to unsolicited resumes.