Senior Director, GMP QA Operations

Revolution Medicines; San Francisco (CA); On-site; USD 211,000 - 264,000; Full time

Job summary

Revolution Medicines is seeking a Director of GMP QA Operations to lead QA for clinical and commercial products, ensuring GMP compliance and timely supply across DS/DP/FP. You will partner with CMOs/CDMOs, review batch records and deviations, and drive risk-based decision making.

The role reports to the Executive Director, GMP QA and requires extensive experience in small molecule manufacturing, with a focus on quality systems, inspections, and cross-functional leadership.

Qualifications

• 12+ years of GMP Quality experience in the pharmaceutical industry with focus on small molecule manufacturing.
• 5+ years of managerial experience in GMP quality leadership.
• Experience with clinical, late-stage and commercial manufacturing.
• Proven batch record review, batch release and product disposition oversight.
• Regulatory inspections experience and readiness for FDA/global authorities.
• Ability to lead cross-functional teams and external partners.

Responsibilities

• Lead GMP QA Operations for assigned products and programs with strategic direction.
• Provide end-to-end QA oversight of GMP manufacturing, testing, and packaging activities across DS, DP, FP, and packaging.
• Oversee GMP materials, CMOs, CDMOs, labs, and suppliers for quality alignment.
• Interface with external partners to align quality expectations and timelines.
• Review deviations, investigations, CAPAs, and change controls impacting release.
• Support regulatory submissions, inspections, and product lifecycle activities.

Skills

GMP QA leadership

External partner mgmt

Cross-functional leadership

Regulatory inspections

Batch release oversight

Quality risk assessment

CAPA management

Batch record review

OOS/OOT investigations

CMO/CDMO oversight

Oral solid dosage

Education

Bachelor's degree in a scientific or technical discipline

Job description

Revolution Medicines is seeking a Director of GMP QA Operations to lead QA for clinical and commercial products, ensuring GMP compliance and timely supply across DS/DP/FP. You will partner with CMOs/CDMOs, review batch records and deviations, and drive risk-based decision making.

The role reports to the Executive Director, GMP QA and requires extensive experience in small molecule manufacturing, with a focus on quality systems, inspections, and cross-functional leadership.