Revolution Medicines · 1 week 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. They are seeking a Senior Manager, GMP Quality, who will provide leadership and operational support for quality assurance programs, emphasizing process validation and commercial readiness.
Health CareLife ScienceMedical
Responsibilities
Responsible for providing QA oversight of process validation activities
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 supporting process validation strategies and oversight of PPQ documentation such as Validation Master Plans (VMP), Criticality Analysis (CA), Risk Assessments (RA), Validation Protocols and Reports. Also provide QA oversight to deviation investigations and change controls associated with PPQ activities
Lead efforts for QA oversight of the manufacture, validation, and disposition of PPQ and commercial product materials, including drug substance (DS), drug product (DP), and final product (FP) at CMOs in partnership with PDM (CMC), Supply Chain, Analytical Development, Quality Control and other functions
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
Provide Quality oversight as well as review and approval of CMO documentation and perform product dispositions, as required
QA lead in periodically reviewing and revising GMP-related SOPs and procedures
Support quality review of regulatory documents (IND/IMPD, NDA) to ensure compliance with late-stage and commercial drug substance (DS) and drug product (DP) validation requirements
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