Senior Director, GMP QA Operations

Socket.dev; Redwood City (CA); On-site; USD 211,000 - 264,000; Full time

Job summary

Revolution Medicines in Redwood City, CA, is seeking a Director of GMP QA Operations to lead quality oversight across Drug Substance, Drug Product, Finished Product and external manufacturing networks. You will ensure GMP compliance, batch disposition accuracy, and inspection readiness while coordinating with cross-functional teams.

The role reports to the Executive Director, GMP QA, and requires strong leadership in risk-based decision making, with collaboration across regulatory, supply chain,

Qualifications

• Bachelor's degree in a scientific or technical discipline.
• 12+ years GMP Quality experience with 5+ years in a managerial role.
• Experience with small molecule manufacturing is essential.
• Proven track record in batch release and product disposition.

Responsibilities

• Lead GMP QA Operations for assigned products and programs.
• Provide end-to-end QA oversight of manufacturing, testing, packaging, and supply.
• Oversee GMP materials, CMOs, CDMOs, labs, and suppliers.
• Interface with external partners to align on quality expectations and timelines.
• Review deviations, investigations, CAPAs, change controls, and investigations.
• Assess risks and escalate significant issues affecting quality or supply.
• Collaborate with cross-functional teams and regulatory to support launches and lifecycle activities.
• Mentor and develop QA team members and drive risk-based decision making.

Skills

GMP QA leadership

Batch release

CMO/CDMO oversight

Regulatory inspections

Pharma manufacturing

Cross-functional leadership

Oral solid dosage

Quality systems

Education

Bachelor's degree in science

Job description

Revolution Medicines in Redwood City, CA, is seeking a Director of GMP QA Operations to lead quality oversight across Drug Substance, Drug Product, Finished Product and external manufacturing networks. You will ensure GMP compliance, batch disposition accuracy, and inspection readiness while coordinating with cross-functional teams.

The role reports to the Executive Director, GMP QA, and requires strong leadership in risk-based decision making, with collaboration across regulatory, supply chain,