GMP Quality Assurance

Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS. Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide.

Our people are united by a shared way of working: follow the science, challenge assumptions, act with urgency and hold ourselves to a high standard of rigor—all in service of patients.

The Opportunity:

The Associate Director, GMP Quality Assurance will provide quality oversight and decision-making authority for development, technology transfe , manufacture, testing, and batch disposition of small molecule Drug Substance (DS) and Drug Product Intermediate (DPI). The role ensures GMP compliance, product quality, data integrity, and inspection readiness for late-stage clinical and commercial programs.

This role will be the primary Quality partner to Technical Operations, CMC, Regulatory, Supply Chain, Analytical Development, and external CDMOs, with end-to-end oversight of DS and DPI manufacturing, quality events, validation, release, and continuous improvement.

Key Responsibilities include:

• Provide QA oversight and disposition support for clinical and commercial small molecule DS and DPI batches, ensuring compliance with GMPs, regulatory filings, specifications, and internal standards.

• Review and approve master and executed batch records, specifications, methods, certificates of analysis, and release packages.

• Review and approve deviations, investigations, OOS/OOT results, change controls, CAPAs, and risk assessments affecting DS and DPI; ensure scientifically sound product-impact evaluations.

• Lead Quality Governance and operational meetings with CDMOs and contract laboratories to align on manufacturing readiness, issue escalation, release timelines, and performance.

• Provide QA oversight for technology transfer, scale-up, process validation/PPQ, cleaning validation, analytical method transfer, and continued process verification.

• Support CMC submissions, inspections, lifecycle changes, and health authority responses.

• Maintain inspection readiness and the GMP Quality System through SOPs, supplier qualification, metrics, and oversight of critical materials, CDMOs, and laboratories.