Senior GMP QA Lead for Small Molecule DS/DPI

Revolution Medicines; San Francisco (CA); On-site; USD 186,000 - 233,000; Full time

Job summary

Revolution Medicines, a late-stage clinical oncology company, seeks an Associate Director for GMP Quality Assurance to oversee DS/DPI batches, ensure GMP compliance, and support CMC submissions. You will partner with Technical Operations and CDMOs to maintain quality and inspection readiness for clinical and commercial programs.

Ideal candidates bring 10+ years in GMP quality, strong risk assessment and leadership, and experience with DS/DPI manufacturing, validation, and regulatory filings.

Qualifications

• Bachelor's degree in a scientific or technical discipline.
• 10+ years of progressive GMP Quality experience in late-stage or commercial DS/DPI.
• Quality oversight of CDMOs supporting technology transfer, validation/PPQ, manufacturing, testing, and batch release.
• Inspection readiness experience in the United States and ex-US markets.

Responsibilities

• Provide QA oversight and disposition for clinical and commercial DS/DPI batches, ensuring GMP compliance and release readiness.
• Review and approve master and executed batch records, specifications, COAs, and release packages.
• Review deviations, investigations, OOS/OOT, CAPAs, changes controls, and risk assessments.
• Lead Quality Governance meetings with CDMOs and contract labs on manufacturing readiness and timelines.
• Provide QA oversight for technology transfer, scale-up, process validation/PPQ, cleaning validation, and method transfer.
• Support CMC submissions, inspections, lifecycle changes and health authority responses.
• Maintain GMP Quality System and inspection readiness through SOPs and supplier qualification.

Skills

GMP quality experience

CDMO oversight

Inspection readiness

CMC submissions

Data integrity

Regulatory knowledge

Risk assessment

Leadership

Stakeholder management

Multi-priority management

Analytical thinking

MS Office

Education

Bachelor's degree

Tools

Electronic quality management systems

Job description

Revolution Medicines, a late-stage clinical oncology company, seeks an Associate Director for GMP Quality Assurance to oversee DS/DPI batches, ensure GMP compliance, and support CMC submissions. You will partner with Technical Operations and CDMOs to maintain quality and inspection readiness for clinical and commercial programs.

Ideal candidates bring 10+ years in GMP quality, strong risk assessment and leadership, and experience with DS/DPI manufacturing, validation, and regulatory filings.