Director, GMP QA Operations

Revolution Medicines seeks a Director of GMP QA Operations to lead quality oversight for assigned clinical and commercial oncology products. The role manages GMP compliance across external manufacturing partners and suppliers, overseeing drug substance through packaged product, and ensures batch disposition and regulatory readiness.

Responsibilities

• Serve as primary GMP QA lead for assigned products, providing quality oversight and strategic direction
• Review batch records, testing documentation, and GMP materials; perform batch disposition decisions
• Oversee external manufacturing partners and suppliers; conduct quality assessments and trend analysis
• Lead quality interactions with external partners on expectations, risks, and release timelines
• Review and approve deviations, investigations, CAPAs, and change controls for quality events

Requirements

• Extensive GMP quality assurance experience in pharmaceutical manufacturing oversight
• Proven leadership in managing external CMOs, CDMOs, and supplier quality networks
• Strong knowledge of batch record review, deviation investigation, and CAPA processes
• Experience supporting regulatory submissions, health authority inspections, and product launches
• Demonstrated expertise in quality risk assessment and compliance issue resolution
• Cross-functional collaboration experience with supply chain and manufacturing teams