Associate Director, GMP Quality Assurance – Small Molecules

Socket.dev; Redwood City (CA); On-site; USD 186,000 - 233,000; Full time

Job summary

Revolution Medicines seeks a senior quality leader to provide GMP QA oversight for DS/DPI development, manufacturing and testing. You will partner with Technical Operations, CMC, Regulatory, and external CDMOs to ensure product quality, data integrity, and timely release across late-stage programs.

The role includes reviewing batch records, COAs, deviations, investigations, CAPAs, and risk assessments, while maintaining inspection readiness and a compliant GMP quality system.

Qualifications

• Bachelor's degree in a scientific or technical discipline is required.
• 10+ years of progressive GMP Quality experience, including late-stage or commercial small molecule DS/DPI manufacturing.
• Quality oversight of CDMOs supporting tech transfer, validation/PPQ, manufacturing, testing, and batch release.
• Inspection readiness experience in US and ex-US markets.
• Knowledge of US and global GMP regulations and industry practices.

Responsibilities

• Provide QA oversight and disposition support for clinical and commercial DS and DPI batches, ensuring GMP compliance and release.
• Review and approve batch records, specifications, COAs, and release packages.
• Approve deviations, investigations, OOS/OOT results, change controls, CAPAs, and risk assessments.
• Lead Quality Governance meetings with CDMOs and contract labs to align on manufacturing readiness and timelines.
• Provide QA oversight for tech transfer, scale-up, process validation/PPQ, cleaning validation, analytical method transfer, and ongoing verification.
• Support CMC submissions, inspections, lifecycle changes, and health authority responses.

Skills

QA oversight

CDMO collaboration

GMP knowledge

Risk assessment

Leadership

Stakeholder management

Process validation

Regulatory submissions

Documentation management

Microsoft Office

Education

Bachelor's degree in a scientific or technical discipline

Tools

LIMS

eQMS / electronic quality management system

Job description

Revolution Medicines seeks a senior quality leader to provide GMP QA oversight for DS/DPI development, manufacturing and testing. You will partner with Technical Operations, CMC, Regulatory, and external CDMOs to ensure product quality, data integrity, and timely release across late-stage programs.

The role includes reviewing batch records, COAs, deviations, investigations, CAPAs, and risk assessments, while maintaining inspection readiness and a compliant GMP quality system.