Associate Director, GMP Quality Assurance

Revolution Medicines • Redwood City, CA

4h • $186,000 - $233,000 • Onsite

About The Position

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity:
The Associate Director, GMP Quality Assurance will play a critical role in providing quality oversight and decision-making authority for commercial manufacturing and batch release activities across Drug Substance (DS), Drug Product Intermediate (DPI), Drug Product (DP), and Commercial Packaging operations. This position is responsible for ensuring GMP compliance, product quality, and inspection readiness throughout the commercial supply chain and in late-stage clinical programs transitioning to commercialization.
This role will serve as a key Quality partner to internal cross-functional teams and external CDMOs, packaging vendors, and suppliers, with a strong focus on end-to-end batch disposition, deviation management, and continuous improvement of commercial quality processes.

Requirements

• A Bachelor's degree in a scientific or technical discipline is required.
• A minimum of 10 years of experience in GMP Quality in the pharmaceutical industry, with experience in late-stage drug product development and commercial activities.
• Experience managing quality aspects of development, validation, manufacturing, and testing activities at CMOs.
• Experience in Inspection Readiness (domestic and ex-US).
• Excellent analytical skills and a strong technical background in small molecule process development, validation, and testing are strongly desired.
• Knowledge of applicable US and Global compliance regulations and industry practices.
• Ability to critically evaluate and troubleshoot complex problems with diligence.
• Strong teamwork, collaboration, and management skills.
• Ability to manage multiple priorities and aggressive timelines.
• Highly responsible, self-motivated professional with enthusiasm and passion for the work.
• Highly proficient with various Microsoft and other computerized systems (e.g., Word, Outlook, Excel, PowerPoint, Visio, etc.).
• Experience in working with external partners, contract manufacturing/packaging organizations.
• Experience with the preparation and/or review of regulatory filing submissions (IND/IMPD/NDA).

Nice To Haves

• Experience in Commercial batch disposition is preferred.

Responsibilities

• Provide QA oversight, review and final disposition support for commercial DS, DPI, DP, and commercial packaged product batch release, ensuring compliance with GMPs, regulatory filings, and internal quality standards.
• Review and approve quality events including deviations, investigations, OOS/OOT results, change controls, CAPAs, and specification-related documents impacting batch release.
• Lead Quality Governance forums and operational meetings with CDMOs and packaging partners to ensure alignment on quality expectations, timelines, and release readiness.
• Support and maintain a robust GMP Quality System, including SOP development, review, and approval; vendor qualification; and ongoing supplier oversight.
• Support regulatory submissions, inspections, and post-approval lifecycle activities, including supplements, variations, and responses to health authority inquiries.
• Maintain CPV data, quality metrics and KPI trend analysis for commercial batches.
• Provide GMP Quality Assurance support for clinical development programs and ongoing process validation activities across Drug Substance, Drug Product, and packaging operations.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level