Revolution Medicines · 2 days ago
Senior Manager, GMP Quality
San Francisco Bay Area
Full-time
Onsite
Senior Level, Lead/Staff
$158K/yr - $198K/yr
8+ years expRevolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies for RAS-addicted cancers. The Senior Manager, GMP Quality will provide leadership and operational support for Quality Assurance, ensuring compliance with quality standards throughout the development phases of clinical and commercial products.
Health CareLife ScienceMedical
Responsibilities
Responsible for providing QA oversight of all Quality Control activities including but not limited to test method validations, product specifications, stability programs, etc
Represent QA on cross-functional teams and serve as a resource for quality and compliance questions, issues, and planning across the development organization, including providing guidance based on current global regulations, industry standards, and best practices
Collaborate with internal and external stakeholders on deviation investigations, OOX investigations, CAPA plans, change controls, shelf-life extensions and revisions to documentation
Lead efforts for QA oversight of the manufacture and disposition of pre-clinical, clinical, and commercial product materials, DS, DP, and FP at CMOs in partnership with PDM (CMC), Supply Chain, Analytical Development, and other functions
Execution of Quality Systems as Quality SME for Deviations, CAPAs, Change Controls, and other Quality processes
Lead and actively participate in continuous improvement initiatives and projects, ensuring a focus on increasing both efficiency and quality output from all processes used by cross-functional partners
Establish and maintain internal quality metrics for the GMP Quality group that predict the performance and health of the quality systems and processes and effectively communicate compliance-related metrics, risks, and compliance challenges to senior management
In collaboration with the Analytical Development function, provide quality oversight for GMP activities including, approval of Method Validation, Specifications, Release testing, and Stability for Drug Substance and Drug Products
Review and approval of CMO documentation (e.g., specification documents, master batch records, label proofs, etc.) as well as review executed batch records, applicable test data (in-process and release), and performing product dispositions
QA lead in periodically reviewing and revising GMP-related SOPs and procedures
Support quality review of regulatory documents (IND/IMPD, NDA)
Participate in inspection readiness efforts, particularly for late-stage development and commercial launch preparations
Build positive professional relationships and trust to support learning, respect, open communication, collaboration, and teamwork
Qualification
Required
A bachelor's degree in a scientific or technical discipline is required
A minimum of 8 years of experience in GMP Quality in the pharmaceutical industry, with experience in late-stage drug product development and validation, is required
Experience managing quality aspects of development, validation, manufacturing, and testing activities at CMOs, particularly for late-stage DS and DP process validation and commercialization
Experience in process validation (PPQ), late-stage regulatory submissions, and commercial readiness
Experience in Inspection Readiness (domestic and ex-US), particularly related to late-stage drug product validation
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.)
Preferred
Hands-on experience working in a manufacturing environment overseeing QA responsibilities for commercial and late-stage programs 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