GMP QA Lead for DS/DPI & Tech Transfer

Regulatory Jobs; Redwood City (CA); On-site; USD 186,000 - 233,000; Full time

Job summary

Revolution Medicines is seeking an Associate Director, GMP Quality Assurance to provide quality oversight and decision-making for DS and DPI manufacturing, testing, and release across late-stage clinical and commercial programs. You will partner with Technical Operations, CMC, Regulatory, and external CDMOs to ensure GMP compliance and data integrity.

The role requires 10+ years in GMP quality with DS/DPI experience, strong leadership, and experience with regulatory filings and inspections.

Qualifications

• Bachelor's degree in a scientific or technical discipline required.
• 10+ years of progressive GMP Quality experience, including late-stage or commercial small molecule DS/DPI manufacturing.
• Quality oversight of CDMOs for technology transfer, validation/PPQ, manufacturing, testing, and batch release.
• US and ex-US inspection readiness experience.
• Technical knowledge of small molecule chemistry, process controls, impurity management, analytical testing, specifications, and validation.
• Knowledge of US/global GMP regulations and industry practices.
• Experience with deviations, investigations, CAPAs, change controls, and risk assessments.

Responsibilities

• Provide QA oversight and disposition for clinical and commercial DS/DPI batches, ensuring GMP compliance.
• Review and approve batch records, specifications, methods, COAs, and release packages.
• Review deviations, investigations, OOS/OOT, and CAPAs; conduct risk-based product-impact evaluations.
• Lead Quality Governance meetings with CDMOs and labs for manufacturing readiness and release timelines.
• Oversee technology transfer, scale-up, process validation/PPQ, cleaning validation, and analytical method transfer.
• Support CMC submissions, inspections, lifecycle changes, and health authority responses.
• Maintain GMP Quality System via SOPs, supplier qualification, metrics, and oversight of critical materials.

Skills

Bachelor's degree

GMP Quality experience

CDMOs oversight

Inspection readiness

Process validation/PPQ

Risk assessments

Leadership & collaboration

MS Office / electronic quality systems

Education

Bachelor's degree in a scientific or technical discipline

Tools

Microsoft Office

Electronic quality systems

Job description

Revolution Medicines is seeking an Associate Director, GMP Quality Assurance to provide quality oversight and decision-making for DS and DPI manufacturing, testing, and release across late-stage clinical and commercial programs. You will partner with Technical Operations, CMC, Regulatory, and external CDMOs to ensure GMP compliance and data integrity.

The role requires 10+ years in GMP quality with DS/DPI experience, strong leadership, and experience with regulatory filings and inspections.