Executive Director, GCP QA (Good Clinical Practice, Quality Assurance)

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding scientists in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

The Executive Director of GCP QA is a senior leadership role responsible for overseeing the quality assurance activities related to Good Clinical Practices (GCP) within a global pharmaceutical company. This role is responsible for ensuring compliance with global regulatory requirements, industry standards, and company policies related to clinical trials. The candidate will lead a team of QA professionals, provide strategic leadership, drive continuous improvement initiatives, accountable for quality oversight of contract organizations, and ensure the highest standards of quality and patient safety in clinical research activities. The candidate will represent QA and function as the GCP QA lead and accountable for Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Pharmacovigilance/Safety oversight for all RevMed clinical studies. This position will report to the Vice President, Global QA and an on-site.  Key responsibilities include:

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

• Function as the Clinical QA Lead on all RevMed Clinical study, represent QA in joint and steering committees including making key decisions on all GCP events.

• Oversee the development, implementation, and maintenance of GCP QA policies, procedures, and systems.

• Support the development and review of clinical trial protocols, informed consent forms, and other critical study related documents.

• Review and approve key documents, study protocol, monitoring plans, contracts and all study related essential documents.

• Ensure RevMed clinical studies are in compliance with global GCP regulations (e.g., FDA, EMA, ICH E6 R2/R3) and company standards.

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

• Lead and manage GCP audits, including clinical investigator sites, vendors, clinical trial documentation, and internal processes.

• Host and support regulatory inspections (i.e., BIMO, PV), partner audits and due diligence activities ensuring inspection readiness and timely resolution of findings.

• Review and approve audit reports, CAPA and quality action plans, and follow-up actions to ensure effective resolution of non-conformance and quality events.

• Identify, assess, and mitigate GLP/GCP-related compliance risks across clinical development programs including escalation of critical quality events to sr. management.

• Collaborate with clinical operations, regulatory affairs, and other stakeholders to address quality events and drive continuous improvement.

• Partner with clinical development, regulatory affairs, pharmacovigilance, and other functions to ensure alignment on quality and compliance objectives.

• Partner with clinical operations in selection of CRO’s and other clinical service providers including managing the qualification and ongoing monitoring of GCP vendors, including CROs, central labs, and clinical service providers.

• Ensure contract research vendor compliance with contractual obligations, agreements, and regulatory requirements.

• Build, mentor, and lead a high-performing GCP QA team. Provide training and development opportunities to enhance team capabilities.

• Foster a culture of quality, accountability, and collaboration within the team and across the organization.

• Provide expert guidance on GCP regulations, guidance and compliance to senior management and cross-functional teams.

Required Skills, Experience and Education:

• Undergraduate degree in life sciences, pharmacy, chemistry, or a related field.

• Minimum of 15 years of experience in the pharmaceutical or biotechnology industry, with at least 10 years’ experience working in GCP QA or clinical quality leadership roles.

• Minimum of 5+ years’ experience hosting regulatory BIMO inspections (e.g., FDA, EMA, PMDA) and managing GCP audit programs.

• Proven track record and relevant indu