The Opportunity:

Revolution Medicines is seeking an Associate Director, Clinical Quality Assurance, who will play a key role within Quality Assurance and is responsible for providing leadership and compliance support for RevMed sponsored clinical trials with respect to RevMed’s Standard Operating Procedures, applicable regulatory requirements (FDA, EU, ICH & country-specific), and current industry standards and practices.

• Support the development and maintenance of applicable Quality Systems and procedures that comply with applicable GCP standards and guidelines.

• Collaborate with clinical functions (e.g., Clinical Operations, Clinical Development) to provide GCP compliance support.

• Participate in clinical study execution teams (CSETs) to enable risk-based quality management and a culture of quality and open dialogue.

• Perform quality review of clinical trial documents with a focus on compliance / regulatory requirements and risk management.

• Collaborate with internal stakeholders, external auditors, and auditees to support the planning, preparation, conduct, reporting, and closure of GCP audits.

• Provide risk-based quality oversight for clinical trial activities and perform routine clinical vendor assessments.

• Provide support for Inspection Readiness activities (e.g., TMF activities, study documentation).

• Assess and coordinate activities relevant to potential quality issues associated with GCP and clinical trial conduct including but not limited to investigations, and root cause analysis, CAPA planning and management.

• Escalate identified issues to QA Management and other relevant leadership as needed in a timely manner.

• Enable other assigned GCP or GXP related tasks, as appropriate.

• Support GCP audits and inspections of RevMed, Vendors, and clinical investigator sites by regulatory authorities or business partners.

• Build positive professional relationships and trust to support learning, respect, open communication, collaboration, and teamwork.

Required Skills, Experience and Education:

• Bachelor’s degree in scientific or technical discipline.

• A minimum of 10+ years of experience in GCP Quality in the pharmaceutical or biotechnology industry.

• 8 years in any of the following areas: audit or audit management experience, inspection readiness, Deviation/CAPA management, or related quality management system responsibilities.

• Extensive knowledge of ICH GCP, other relevant ICH guidelines and regulatory requirements (minimally US FDA) regarding applicable drug development regulations.

• Effective communication (verbal and written).

• Ability to build and sustain positive relationships with GxP colleagues, internal stakeholders, and external partners.

• Ability to create innovative solutions to problems, while integrating stakeholder input and feedback.

• Ability to critically evaluate and troubleshoot complex problems with diligence.

• Ability to manage multiple priorities and aggressive timelines.

• Highly responsible, self-motivated professional with enthusiasm and passion for the work.

• Highly proficient with various Microsoft and other computerized systems (e.g., Word, Outlook, Excel, PowerPoint, Visio, etc.).

Preferred Skills:

• Good knowledge of Computer System Validation. 

  #LI-Hybrid #LI-JC1

The Opportunity:

The Executive Director of GCP QA is a senior leadership role responsible for setting and executing the global GCP quality strategy across clinical development programs. This position ensures compliance with regulatory requirements, industry standards, and company policies governing clinical trials. The role provides strategic oversight of GCP QA activities, including leadership of a high-performing QA team, governance of contract research organizations, and advancement of continuous improvement initiatives to uphold the highest standards of quality and patient safety.

Serving as the GCP QA lead for late-stage clinical programs, this individual is accountable for GCP, GLP, and Pharmacovigilance/Safety oversight across multiple RevMed studies and represents QA in cross-functional and executive forums. The Executive Director will serve as a key advisor to senior leadership on clinical quality risk and regulatory readiness, helping to shape development strategy and enable successful regulatory outcomes. This position reports to the Vice President, Global Quality.

Key Responsibilities:

• Develop and execute the global GCP QA strategy aligned with corporate objectives, regulatory requirements, and RevMed SOPs.

• Serve as the Clinical QA Lead for global Phase 2/3 oncology studies, representing QA in governance forums and providing decision-making oversight on GCP related matters.

• Establish and maintain GCP QA frameworks, including policies, procedures, systems, and risk-based quality management (RBQM) to ensure compliance with global regulations (FDA, EMA, ICH).

• Provide end-to-end QA oversight of clinical studies, including:

• Review and approval of key study documents (protocols, monitoring plans, vendor oversight plans, quality agreements)

• Trial Master File (TMF) quality and inspection readiness

• GxP computerized systems and data integrity controls

• Lead and oversee GCP audit and inspection activities, including investigator sites, vendors, internal processes, and regulatory inspections (e.g., BIMO, PV), ensuring timely resolution of findings and CAPAs.

• Serve as the primary QA interface with global regulatory authorities, leading inspection strategy and representing the organization during health authority interactions.

• Drive global inspection readiness through structured planning, mock inspections, and cross-functional preparedness activities to support successful regulatory submissions and approvals.

• Oversee vendor and CRO quality management, including selection, qualification, governance models, performance monitoring (KPIs), and compliance with quality agreements.

• Proactively identify and mitigate systemic quality risks across the clinical portfolio, influencing development strategies and ensuring effective escalation to senior leadership.

• Monitor, trend, and report quality metrics (e.g., KPIs, QTLs, TMF health, CAPAs), leveraging insights to drive continuous improvement and operational excellence.

• Provide QA oversight of pharmacovigilance activities, ensuring compliance with safety reporting requirements and vendor performance expectations.

• Partner cross-functionally with Clinical Development, Clinical Operations, Regulatory Affairs, and Pharmacovigilance to drive quality, compliance, and continuous improvement.

• Drive innovation in QA through adoption of digital tools, advanced analytics, and modern risk-based quality approaches.

• Build, scale, and lead a high-performing global GCP QA organization, fostering a culture of quality, accountability, and operational excellence.

• Serve as a subject matter expert on GCP/GLP/PV regulations, advising senior leadership and influencing quality strategy across the organization.

Required Skills, Experience and Education:

• Advanced degree in life sciences, pharmacy, chemistry, or a related field (PhD, MS, or equivalent preferred).

• Minimum of 15 years of experience in the pharmaceutical or biotechnology industry, including at least 10 years in GCP QA or clinical quality leadership roles, with demonstrated experience leading and hosting regulatory inspections (e.g., FDA BIMO, EMA, MHRA, PMDA).

• Demonstrated experience interacting directly with global health authorities and leading inspection strategy and execution.

• Experience supporting late-stage clinical development and regulatory submissions (e.g., NDA, MAA), preferably in oncology.

• Proven track record and relevant industry experience in leading GCP QA functions within a global organization, preferably in oncology.

• Strong knowledge of global GCP regulations, ICH guidelines, and clinical trial processes.

• Excellent leadership, communication, team building and people skills, with the ability to influence stakeholders at all levels.

• Analytical thinker with a focus on continuous improvement and innovation.

• Experience working within outsourced clinical trial models and managing global CRO/vendor networks is highly desirable.

• This role may require occasional travel (up to 15%) for audits, inspections, and meetings.

• Flexibility to work in a fast-paced, dynamic environment with evolving priorities.

Preferred Skills:

• Experience implementing advanced RBQM frameworks and leveraging analytics-driven approaches (e.g., centralized monitoring, signal detection) to enhance clinical quality oversight.

• Prior experience in a small-to-mid-size biotech environment, with demonstrated ability to build and scale QA functions within highly outsourced, global clinical development models. 

  #LI-Hybrid  #LI-GL1

The Opportunity:

The Executive Director, Head of Quality, Europe is responsible for leading and overseeing all Quality functions across the European region, ensuring compliance with European regulatory requirements. This role provides strategic and operational leadership across GxP Quality (GMP, GDP, GCP as applicable). In addition, this role serves as the key Quality representative for Europe, partnering closely with Regulatory Affairs, Manufacturing, Supply Chain, Clinical Operations, and external partners to ensure a robust and inspection-ready quality system.

Key Responsibilities:

• Lead and develop the European Quality organization, ensuring alignment with global quality strategy and supporting the transition from clinical to commercial operations.

• Act as the primary Quality representative for Europe, providing leadership in regional and global governance forums and serving as the main interface with European regulatory authorities (e.g., EMA, national agencies).

• Ensure Quality oversight of MAH responsibilities, including lifecycle management, product complaints, recalls, and fulfillment of regulatory commitments in close collaboration with Regulatory Affairs.

• Establish, implement, and maintain an effective EU Quality Management System (QMS) in compliance with EU GMP, GDP, GCP (as applicable), and ICH guidelines.

• Participate in cross-functional review of Global SOPs, ensuring timely harmonization and effective implementation within the EMEA region.

• Oversee key quality system processes, including deviations, CAPAs, change control, risk management, product quality complaints, and document management.

• Monitor QMS performance through KPIs, risk indictors and management review process.

• Review quality agreements to ensure compliance with EU GMP, GDP and other regulatory requirements across the supply chain.

• Define and oversee the EU QP framework, ensuring compliant batch certification and appropriate governance of internal and/or contracted QPs.

• Ensure full compliance with EU GDP requirements, including oversight of distribution activities, wholesale authorizations, and Responsible Person (RP) functions within the EU supply network.

• Provide end-to-end Quality oversight of external partners (e.g., CMOs, 3PLs, distributors), including quality agreements, performance monitoring, and risk-based governance.

• Lead inspection readiness across Europe and manage regulatory inspections and internal/external audits, ensuring consistent positioning and effective interaction with authorities.

• Support regulatory submissions and lifecycle activities by ensuring quality oversight of relevant documentation and CMC components.

• Provide Quality leadership for new product introductions, technology transfers, and commercial launches in Europe, ensuring readiness of systems, processes, and partners.

• Collaborate cross-functionally with Regulatory Affairs, Technical Operations, Supply Chain, Clinical Operations, and Global Supplier Quality to ensure integrated and compliant execution across the product lifecycle.

• Drive a strong, proactive quality culture across all European operations, promoting continuous improvement and accountability.

Required Skills, Experience and Education:

• Degree in Life Sciences, Pharmacy, Chemistry, or related field (PhD, PharmD, or MSc preferred).

• 20+ GxP Quality within the pharmaceutical industry.

• Track record of building and scaling Quality organizations.

• Track record of working in a GMP/GDP regulated environment.

• Deep knowledge of European regulatory requirements (EMA, EU GMP/GDP, ICH guidelines).

Preferred Skills:

• Biotech experience.

• Significant leadership experience, including managing regional or global teams.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com. 

#LI-Remote #LI-LO1

The Opportunity:

The Executive Director, Head of Quality, Europe is responsible for leading and overseeing all Quality functions across the European region, ensuring compliance with European regulatory requirements. This role provides strategic and operational leadership across GxP Quality (GMP, GDP, GCP as applicable). In addition, this role serves as the key Quality representative for Europe, partnering closely with Regulatory Affairs, Manufacturing, Supply Chain, Clinical Operations, and external partners to ensure a robust and inspection-ready quality system.

Key Responsibilities:

• Lead and develop the European Quality organization, ensuring alignment with global quality strategy and supporting the transition from clinical to commercial operations.

• Act as the primary Quality representative for Europe, providing leadership in regional and global governance forums and serving as the main interface with European regulatory authorities (e.g., EMA, national agencies).

• Ensure Quality oversight of MAH responsibilities, including lifecycle management, product complaints, recalls, and fulfillment of regulatory commitments in close collaboration with Regulatory Affairs.

• Establish, implement, and maintain an effective EU Quality Management System (QMS) in compliance with EU GMP, GDP, GCP (as applicable), and ICH guidelines.

• Participate in cross-functional review of Global SOPs, ensuring timely harmonization and effective implementation within the EMEA region.

• Oversee key quality system processes, including deviations, CAPAs, change control, risk management, product quality complaints, and document management.

• Monitor QMS performance through KPIs, risk indictors and management review process.

• Review quality agreements to ensure compliance with EU GMP, GDP and other regulatory requirements across the supply chain.

• Define and oversee the EU QP framework, ensuring compliant batch certification and appropriate governance of internal and/or contracted QPs.

• Ensure full compliance with EU GDP requirements, including oversight of distribution activities, wholesale authorizations, and Responsible Person (RP) functions within the EU supply network.

• Provide end-to-end Quality oversight of external partners (e.g., CMOs, 3PLs, distributors), including quality agreements, performance monitoring, and risk-based governance.

• Lead inspection readiness across Europe and manage regulatory inspections and internal/external audits, ensuring consistent positioning and effective interaction with authorities.

• Support regulatory submissions and lifecycle activities by ensuring quality oversight of relevant documentation and CMC components.

• Provide Quality leadership for new product introductions, technology transfers, and commercial launches in Europe, ensuring readiness of systems, processes, and partners.

• Collaborate cross-functionally with Regulatory Affairs, Technical Operations, Supply Chain, Clinical Operations, and Global Supplier Quality to ensure integrated and compliant execution across the product lifecycle.

• Drive a strong, proactive quality culture across all European operations, promoting continuous improvement and accountability.

Required Skills, Experience and Education:

• Degree in Life Sciences, Pharmacy, Chemistry, or related field (PhD, PharmD, or MSc preferred).

• 20+ GxP Quality within the pharmaceutical industry.

• Track record of building and scaling Quality organizations.

• Track record of working in a GMP/GDP regulated environment.

• Deep knowledge of European regulatory requirements (EMA, EU GMP/GDP, ICH guidelines).

Preferred Skills:

• Biotech experience.

• Significant leadership experience, including managing regional or global teams.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com. 

#LI-Hybrid #LI-LO1

The Opportunity:

• The Associate Director (AD) Good Laboratory Practice Quality Assurance (GLP QA) is responsible for ensuring Good Laboratory Practices (GLP) compliance at RevMed and external vendors contracted to perform regulated work on behalf of RevMed including all GLP vendors.

• The AD GLP QA responsibilities include for research laboratory vendors that perform work to support regulated clinical studies.

• The AD GLP QA develops the annual vendor audit plan.

• The AD GLP QA performs and/or manages vendor audits including:

  • Development of the audit plan, audit conduct, and reporting

  • Tracking and coordination of audit closure tasks including review of observation responses from vendor(s) in conjunction with operational subject matter experts (SMEs), as applicable.

  • Provision of vendor approval recommendations

  • Maintenance of vendor approval status in Veeva.

• The AD GLP QA performs or participates in internal audits.

• The AD GLP QA provides QA review of CRO study protocols and reports for compliance utilizing a risk-based approach, as needed and serves as an advisor to the Nonclinical Development and Clinical Pharmacology (NDCP) to resolve compliance issues.

• The AD GLP QA monitors vendor QA units for compliance with applicable regulations including review of vendor study specific QA audit reports.

• The AD GLP QA advises Sponsor(s) on compliance requirements for test and control article used in GLP studies.

• The AD GLP QA liaises and/or consults with GLP vendor QA departments on study-related issues such as deviations, investigations, CAPAs and other compliance issues.

• The AD GLP QA provides annual GLP training or liaises with an external trainer to provide GLP training to RevMed functional team(s).

• The AD GLP QA attends functional area meetings (e.g., NDCP and Biomarker group) to discuss and review new or on-going issues, projects, and/or studies.

• The AD GLP QA works with QA management for resource planning, as needed.

• The AD GLP QA attends periodic clinical QA group meetings, as needed.

• The AD GLP QA provides periodic quality and compliance updates to QA management.

• The AD GLP QA develops/prepares standard operating procedure (SOPs) content to GLP audits, and reviews functional area and QA SOPs for GLP compliance.

• The AD GLP QA provides consultative QA guidance for computerized system vendors (and systems) supporting GLP studies.

Required Skills, Experience and Education:

• Bachelor’s or Master’s Degree.

• 12+ years of experience in global Good Laboratory Practice (GLP) Quality Assurance (QA).

• Extensive audit and inspection management experience.

Preferred Skills:

• Registered Quality Assurance Professional – Good Laboratory Practice (RQAP-GLP).

• Planning and scheduling expertise.

• Experienced in effective prioritization of competing initiatives and tasks across multiple projects.

• Ability to communicate effectively with senior leadership, management and cross functional teams.

• Ability to manage workstreams to maintain delivery timelines through disciplined planning, tracking and follow-up.

• Ability to balance detail-oriented execution with strategic oversight.

• Experienced with the proactive identification, assessment and mitigation of risks and with timely issue escalation, as applicable.

• Regulatory expertise with at least the following regulations and guidance:

  • 21CFR Part 58 Good Laboratory Practice

  • 21 CFR Part 11 Electronic Records; Electronic Signatures

  • OECD #1 – 24 Standards and Advisory Documents on Good Laboratory Practices

  • ICH E6 (R2 and R3) Good Clinical Practices

  • Japanese Ministry of Health Labor and Welfare (MHLW) – Good Laboratory Practice

  • Applicable US and EU guidance documents including bioanalytical, in vitro and in vivo genetic, Phototox, and hERG toxicology studies

• Experience with the following audit types.

• Testing facilities.

• Bioanalytical and PK data analysis Labs.

• hERG and Phototoxicity testing facilities.

• Archives – biorepositories, paper and electronic data storage.

• Computer Systems Validation.

• Biomarker Labs (including Artificial Intelligence and Machine Learning).

• Central Laboratories. 

  #LI-Hybrid #LI-JC1

The Opportunity:

The Qualified Person (QP) holds ultimate responsibility for the certification and release of medicinal products in accordance with EU GMP, Directive 2001/83/EC, Dutch pharmaceutical legislation, and applicable Marketing Authorisations.

The role provides independent, authoritative quality leadership across site operations and serves as a key member of the site leadership team, ensuring patient safety, product quality, regulatory compliance, and reliable supply.

In addition to batch release accountability, the QP provides strategic oversight of the Pharmaceutical Quality System, partners closely with senior stakeholders across Quality, Technical Operations, Supply Chain, and Regulatory Affairs, and represents the site in interactions with Health Authorities.

• Regulatory Accountability & Product Release

  • Act as the legally registered Qualified Person with full authority for certification and release of clinical and commercial medicinal products.

  • Ensure batch certification in compliance with EU GMP, Directive 2001/83/EC, national legislation, EU GMP Annex 16, the applicable Marketing Authorisation, and approved regulatory dossiers (e.g., MA, IMPD), and applicable authorisations.

  • Exercise independent decision-making authority, including batch rejection and escalation when required.

  • Ensure timely batch disposition aligned with supply commitments and compliance requirements.

  • Responsible for the certification and release of Investigational Medicinal Products (IMPs) in accordance with EU Clinical Trial Regulation and EU GMP Annex 13, including oversight of randomisation, blinding, labelling, comparators, and clinical supply chain integrity.

  • Maintain QP oversight of the end‑to‑end GMP supply chain, including qualification, approval, and ongoing monitoring of contract manufacturers, testing laboratories, API suppliers, and logistics providers.

• Quality System Leadership

  • Provide oversight of the Pharmaceutical Quality System, ensuring inspection readiness and regulatory alignment.

  • Oversee deviations, CAPAs, change controls, investigations, complaints, and recalls.

  • Approve critical GMP documentation including SOPs, validation documentation, and quality agreements.

  • Ensure that third‑country manufacturing sites comply with EU GMP requirements, including audit strategy, GMP equivalence assessment, and importation controls.

  • Provide QP oversight of data integrity governance across GMP processes and computerized systems, ensuring adherence to ALCOA+ principles, validated system use, appropriate audit trails, and timely escalation of data integrity risks that may impact batch certification or regulatory complian

  • Oversee continued process and product verification activities, including stability programs, ongoing trend analysis, and Product Quality Reviews (PQR/APQR), ensuring that emerging quality risks are identified, assessed, and managed proactively throughout the product lifecycle.

• Strategic & Cross-Functional Leadership

  • Act as a strategic quality partner to site and functional leadership.

  • Lead quality risk assessments related to manufacturing operations and change initiatives.

  • Mentor QA professionals and support QP succession and capability building.

  • Embed a proactive quality culture across the organization.

• Regulatory & External Representation

  • Serve as primary QP representative during inspections and Health Authority interactions.

  • Lead inspection readiness and coordinate regulatory responses.

  • Maintain oversight of recall activities.

• Performance, Governance & Escalation

  • Define and present quality KPIs, trends, and risk assessments to senior management.

  • Drive continuous improvement using data-driven insights and benchmarking.

  • Provide escalation support during critical quality events.

  • Act independently in the execution of QP duties, maintain direct access to senior management for escalation of critical quality, compliance, or patient safety risks, and ensure that QP certification decisions are not compromised by commercial or supply pressure.

  • Maintain an effective interface with Pharmacovigilance to ensure timely assessment and escalation of quality‑related safety signals, quality defects, recalls, and Rapid Alerts, in accordance with regulatory expectations and patient safety requirements.

Required Skills, Experience and Education:

• Master's degree in Pharmacy, Chemistry, Biotechnology, or relevant scientific discipline.

• 9+ years experience working in quality related roles with increasing responsibility.

• Eligibility for registration as a Qualified Person under Dutch pharmaceutical legislation.

• Extensive experience as a Qualified Person with direct batch release accountability.

• Deep working knowledge of EU GMP and relevant regulatory frameworks.

• Proven inspection experience and senior stakeholder engagement capability.

• Fluency in English; Dutch language skills are an advantage.

• Risk-based, pragmatic mindset balancing compliance and supply reliability.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com. 

#LI-Remote #LI-LO1

The Opportunity:

• Provide strategic and operational leadership to scale and globalize the Quality Management System (QMS), establishing a harmonized, flexible framework that supports international growth and regulatory compliance.

• Lead oversight and expansion of core quality systems across global sites, including document control, GxP training, quality events, supplier management, audits, and batch release.

• Partner with regional teams (including Japan, Europe & other global regions) to integrate local regulatory requirements into the global QMS while maintaining global consistency.

• Establish and govern global quality procedures, including policies, SOPs, and standardized processes to ensure compliance and operational efficiency.

• Ensure inspection readiness and lead support for global health authority inspections, regulatory submissions, and product launches.

• Oversee global quality metrics, compliance monitoring, and management review processes; drive proactive identification, escalation, and mitigation of quality risks.

• Provide governance for electronic quality and validated GxP systems (e.g., Veeva Vault Quality), ensuring they effectively support global operations.

• Collaborate cross-functionally to build and sustain a scalable quality infrastructure aligned with organizational growth and global expansion.

• Champion a culture of continuous improvement and quality excellence across the enterprise.

Required Skills, Experience and Education:

• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or a related discipline (advanced degree preferred).

• Minimum of 10+ years of experience in Quality within the pharmaceutical or biotechnology industry, including leadership of global quality systems.

• Demonstrated experience establishing, leading, and maintaining a global Quality Management System (QMS) across multiple regions.

• Proven ability to influence and align senior stakeholders and executive leadership on quality strategy and risk-based decision making.

• Deep knowledge of global GxP regulations and experience ensuring compliance across international markets (e.g., FDA, EMA, PMDA).

• Proven track record supporting global regulatory filings, approvals, inspections, and post-market quality obligations.

Preferred Skills:

• Experience building or transforming global QMS in a growing organization.

• Prior interaction with FDA, EMA, PMDA, and other global health authorities.

• Experience supporting commercial product launches and lifecycle management. 

  #LI-Hybrid #LI-JC1

The Opportunity:

• Support the Quality Assurance (QA) team in maintaining compliance with internal procedures, regulatory requirements, and quality standards.

• Assist with the review, organization, and maintenance of quality documentation, including SOPs, training records, and quality records.

• Participate in quality system activities such as deviations, CAPAs, change controls, and document control processes.

• Collaborate cross-functionally with Manufacturing, R&D, and other teams to support quality initiatives and continuous improvement efforts.

• Gain hands-on experience in a regulated biotech/pharmaceutical environment while developing a foundational understanding of GMP and quality systems.

Required Skills, Experience and Education:

• Currently pursuing a Bachelor’s or Master’s degree in Life Sciences, Engineering, Chemistry, Biology, Biotechnology, or a related field.

• Strong attention to detail with the ability to follow written procedures and maintain accurate records.

• Basic understanding of quality principles or regulated environments (academic coursework acceptable).

• Proficiency with Microsoft Office (Word, Excel, PowerPoint); ability to learn electronic quality management systems (eQMS).

• Strong written and verbal communication skills.

• Ability to work independently as well as collaboratively in a team environment.

Preferred Skills:

• Prior internship, coursework, or laboratory experience in GMP, GxP, QA, QC, or manufacturing environments.

• Familiarity with FDA regulations, ICH guidelines, or ISO standards.

• Experience with document control systems, quality databases, or data analysis tools.

• Demonstrated interest in quality assurance, regulatory affairs, or compliance-focused career paths. 

  #LI-Hybrid  #LI-AP1

The Opportunity:

• Lead internal audit of GCP systems and relative departments, following up through CAPA implementation.

• Perform GxP internal audits to applicable regulations including completing audit reports and follow-up on corrective actions.

• Perform audits of TMFs for various programs.

• Assure oversight of CROs.

• Understand the clinical development process and demonstrate capability to manage the internal clinical audit program.

• Create and maintain the internal GCP annual audit schedule.

• Demonstrate the ability to multi-task, prioritize work, and independently solve problems.

• Support external audits as needed.

• Collaborate with cross-funstional teams and represent Quality Vendor Management at meetings.

• GxP vendor/supplier program management to ensure compliance with GxP regulations and RevMed internal standards.

• Perform Risk Assessments as needed.

• Update SOPS.

• Create and implement tools to improve compliance, consistency, and efficiency for GCP auditing.

• Provide support in preparation of anticipated regulatory inspections and partner with cross-functional teams.

• Maintain supplier management program, enduring requirements, plans, processes, metrics, and tracking systems for GxP suppliers are established and followed.

• Assure the qualification of GCP/GxP suppliers are being performed and maintained per SOPs and KPIs.

• Support Quality Agreements and/or contracts with suppliers as needed.

• Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures according to RevMed procedures.

• Lead supplier performance metrics to monitor the health of systems, drive proactive identification of risk and mitigate compliance issues.

• Update Veeva, track KPIs, and assure GxP audits completed on time.

• Maintain the approved supplier list.

Required Skills, Experience and Education:

• BA/BS degree in Biological Sciences, Chemistry, or related field and /or equivalent experience and education.

• Minimum experience required: 10+ years of pharmaceutical/Biotech experience experience with a minimum of 5+ years GCP Auditing experience including having audited TMFs.

• Familiar with GCP, GLP regulations in US and EU and ICH requirements.

• ASQ Certified Quality Auditor or equivalent certifications.

• Excellent leadership and people management /development skills.

• Strong written and oral communication skills as well as organizational skills.

• Ability to travel occasionally (up to 25%) to support audits.

• Ability to navigate through rapid growth and adapt to rapid change.

• Direct experience working with Quality System electronic databases.

• Proficiency with Microsoft Office (Excel, Outlook, Powerpoint, Work) required.

Preferred Skills:

• Quality Clinical management experience.

• Strategic thinking and project management skills.

• Direct experience with handling and /or participating in regulatory body inspections.

• Proven ability to develop presentations and analyze complex data.

• Experience working with Veeva Quality System Platform. 

  #LI-Hybrid #LI-JC1

The Opportunity:

The Director of Clinical Quality will play a key role in Quality Assurance and have direct responsibility for the clinical quality workstreams and study teams. This role is responsible for providing quality and compliance oversight for RevMed-sponsored clinical trials with respect to RevMed’s Standard Operating Procedures, applicable regulatory requirements (FDA, EU, ICH & country-specific), and current industry standards and practices. This role will support daily compliance operational activities, evaluate risk, and resolve quality events for early phase through late-phase clinical programs. This role will also be responsible for managing multiple studies including GLP activities that impact clinical studies/data. This role will report to the Head of Clinical Quality.

• Act as the study lead for Phase 3 program(s), provide support and guidance to the Clinical Development and Clinical Operations functions, including but not limited to the following functional areas: Global Patient Safety, Translational Medicine, and Data Management.

• Lead the development and maintenance of applicable GCP Quality Systems procedures that comply with applicable GCP standards and guidelines.

• Work with Quality Leadership to develop a risk-based GCP audit program and compliance strategy for RevMed clinical study programs.

• Manage external GCP auditors and support timely review of audit reports and communicate findings to auditees, cross-functional representatives, and management. Ensure the corrective and preventative action (CAPA) plans adequately address findings and root causes, including effectiveness checks where appropriate.

• Support global regulatory, due diligence and partner inspections at Sponsor including preparing the site, training the staff on regulatory inspection management best practices.

• Represent Clinical Quality during global regulatory inspections at RevMed including supporting regulatory inspections at clinical sites for RevMed clinical studies.

• Oversee study documentation including TMF for accuracy and inspection readiness.

• Perform quality reviews of Clinical Study Documents with a focus on compliance / regulatory requirements and risk assessment. The study documents include but are not limited to: Study Protocols, ICFs, Annual Reports (e.g., DSUR), other subject-facing documents (brochures, recruitment materials), Investigator’s Brochure, and CSR.

• Escalate quality events, IPDs, potential serious breaches to Quality Management and other relevant leadership as needed and in a timely manner including initiating CAPAs and CIs to address major findings and gaps.

• Compile, track GCP quality metrics (KPI) and vendor performance on all RevMed initiated clinical studies and report to quality management on a quarterly basis.

• Partner with GLP team members on activities that may impact GCP studies/data.

• Perform other assigned GCP or GXP tasks, as appropriate.

• Manage a team of clinical QA professionals and contractors and mentor QA staff.

• Build positive professional relationships and trust to support learning, respect, open communication, collaboration, and teamwork.

Required Skills, Experience and Education:

• A Bachelor of Science (B.S.) in a scientific or technical discipline is required.

• Minimum of 15 years of pharmaceutical clinical quality assurance experience providing quality oversight and supporting multiple late-stage clinical studies (Phase II to III).

• Extensive knowledge of relevant ICH E6, FDA, EMA, HC and PMDA and other regulatory requirements and guidance documents, with practical application and execution of GLP and GCP requirements.

• Experience with the application of phase-appropriate quality systems across the product development lifecycle (Phase 1 through Phase III).

• Experience in regulatory inspections and in dealing with regulatory agencies throughout the drug product approval process.

• Professional and respectful communication skills (verbal / written).

• Ability to effectively communicate with business partners and third-party clinical vendors and their quality assurance representatives to ensure RevMed requirements are met and to resolve issues/discrepancies.

• Oral and written presentation skills are needed to address colleagues at all levels of the organization, e.g., internal training presentations, presentations of CRO performance metrics, and coordination of inspection readiness activities.

• Ability to work on multiple projects, manage competing priorities, and collaborate cross-functionally in a dynamic fast-paced environment.

• Ability to contribute to the development, performance monitoring, and continuous improvement initiatives related to the company’s Quality Systems and their associated processes, policies, and procedures.

Preferred Skills:

• Experience managing oncology clinical studies and 4+ years of GLP quality assurance experience is preferred.

• An advanced degree is a plus. #LI-Hybrid  #LI-SH1