Global GMP QA Operations Director

Regulatory Jobs; Redwood City (CA); On-site; USD 211,000 - 264,000; Full time

Job summary

Revolution Medicines is seeking a Director, GMP QA Operations to lead GMP QA activities across clinical and commercial products. This role ensures quality oversight of DS, DP, FP, and packaging, and partners with CMOs/CDMOs to maintain regulatory readiness.

You will drive batch release decisions, manage deviations and CAPAs, and collaborate with cross-functional teams to mitigate risk and ensure uninterrupted supply.

Qualifications

• Bachelor's degree in a scientific or technical discipline required.
• 12+ years in GMP Quality in pharma with small molecule focus; 5+ years in a managerial role.
• Experience supporting clinical, late-stage and commercial manufacturing.
• Strong batch record review, release, and disposition experience.
• Oversight of CMOs/CDMOs, testing labs, packaging sites and suppliers.

Responsibilities

• Lead GMP QA Operations for assigned products and programs.
• Provide end-to-end QA oversight of GMP manufacturing, testing, packaging, and supply.
• Oversee GMP materials, CMOs, CDMOs, labs, packaging sites and suppliers.
• Lead QA interactions with external partners on quality expectations and timelines.
• Review batch records, testing docs, certificates, and batch disposition.
• Evaluate deviations, investigations, OOS/OOT, CAPAs, change controls and other quality events.
• Assess risks and drive timely resolution of quality issues.
• Collaborate with Supply Chain, Manufacturing, Regulatory, and others.
• Support product launches, tech transfers, site changes, and lifecycle activities.
• Assist regulatory submissions and inspections; ensure inspection readiness.
• Oversee supplier qualification and ongoing quality oversight.
• Promote consistent GMP QA practices across products and partners.
• Provide leadership to the QA Operations team and mentor staff.

Skills

GMP QA

Quality leadership

Regulatory inspections

Cross-functional leadership

CMOs/CDMOs oversight

Education

Bachelor's degree in a scientific or technical discipline

Job description

Revolution Medicines is seeking a Director, GMP QA Operations to lead GMP QA activities across clinical and commercial products. This role ensures quality oversight of DS, DP, FP, and packaging, and partners with CMOs/CDMOs to maintain regulatory readiness.

You will drive batch release decisions, manage deviations and CAPAs, and collaborate with cross-functional teams to mitigate risk and ensure uninterrupted supply.