About the job
Revolution Medicines is at the forefront of clinical-stage precision oncology, dedicated to pioneering innovative targeted therapies aimed at combating RAS-addicted cancers. Our robust R&D pipeline features RAS(ON) Inhibitors, specifically designed to inhibit various oncogenic variants of RAS proteins, alongside RAS Companion Inhibitors for synergistic treatment approaches. By joining the Revolution Medicines team, you will be part of a passionate group of professionals committed to enhancing the lives of cancer patients with mutations in the RAS signaling pathway.
Role Overview:
The Associate Director of GMP Quality Assurance is integral to our mission, providing essential quality oversight and authoritative decision-making for commercial manufacturing and batch release activities across Drug Substance (DS), Drug Product Intermediate (DPI), Drug Product (DP), and Commercial Packaging operations. You will play a vital role in ensuring GMP compliance, safeguarding product quality, and maintaining inspection readiness throughout the commercial supply chain and in late-stage clinical programs transitioning to commercial status.
This role also acts as a critical Quality partner for both internal cross-functional teams and external CDMOs, packaging vendors, and suppliers, with an emphasis on comprehensive batch disposition, deviation management, and the continuous enhancement of commercial quality processes.
Key Responsibilities:
- Ensure QA oversight, review, and final disposition support for commercial DS, DPI, DP, and packaged product batch release, maintaining compliance with GMP standards, regulatory requirements, and internal quality directives.
- Review and approve quality events, including deviations, investigations, out-of-specification/out-of-trend results, change controls, CAPAs, and related documentation affecting batch release.
- Facilitate Quality Governance forums and operational meetings with CDMOs and packaging partners to ensure clarity on quality expectations, timelines, and release readiness.
- Support and uphold a robust GMP Quality System through SOP development, review, approval, vendor qualification, and ongoing supplier oversight.
- Assist with regulatory submissions, inspections, and post-approval lifecycle activities, including supplements, variations, and responses to health authority inquiries.
- Monitor CPV data, quality metrics, and KPI trend analysis for commercial batches.
- Provide GMP Quality Assurance support for clinical development initiatives and ongoing process validation across Drug Substance, Drug Product, and packaging operations.