Revolution Medicines · 18 hours ago
Associate Director, GMP Quality Assurance
San Francisco Bay Area
Full-time
Onsite
Lead/Staff, Director/Executive
$186K/yr - $233K/yr
10+ years expRevolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The Associate Director, GMP Quality Assurance will provide quality oversight and decision-making authority for commercial manufacturing and batch release activities, ensuring GMP compliance and product quality throughout the commercial supply chain.
Health CareLife ScienceMedical
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
Qualification
Required
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)
Preferred
Experience in Commercial batch disposition is preferred
Benefits
Competitive cash compensation
Robust equity awards
Strong benefits
Significant learning and development opportunities
Company
Revolution Medicines
Revolution Medicines is an innovative and dynamic organization of expert biologists, chemists, pharmacologists, clinical scientists.
501-1000 employees
H1B Sponsorship
Revolution Medicines has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (13)
2024 (18)
2023 (15)
2022 (8)
2021 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$2.25BKey Investors
Royalty PharmaBoxer CapitalNextech Invest
2025-06-24Post Ipo Debt· $250M
2024-12-02Post Ipo Equity· $750M
2023-03-02Post Ipo Equity· $323.6M
Leadership Team
Luan Wilfong
Chief Human Resources Officer
Steve Kelsey
President
Recent News
Pharmaceutical Technology
2026-01-13
Company data provided by crunchbase