Revolution Medicines · 11 hours ago
Senior Manager, Quality Systems - Deviation, CAPA, CC
Redwood City, California, United States
Full-time
Onsite
Senior Level, Lead/Staff
$164K/yr - $205K/yr
8+ 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 role involves overseeing and managing Change Control, Deviations, and CAPA programs within the Quality Management System, ensuring compliance and continuous improvement.
Health CareLife ScienceMedical
Responsibilities
Provide day-to-day oversight and management for Change Control, Deviations, and Corrective and Preventive Action (CAPA) programs, ensuring effective execution, compliance, and continuous monitoring including improvement of these processes within the Quality Management System (QMS)
Lead or facilitate quality governance forums (e.g., Change Control Review Boards, Deviation/CAPA Review Boards) using risk-based, science-driven decision-making
Ensure timely initiation, investigation, root cause analysis, and closure of deviations and CAPAs in alignment with regulatory expectations and internal quality standards
Collaborate cross-functionally with Regulatory CMC, Analytical Development / Quality Control, Drug Substance, Drug Product, Supply Chain, Clinical Functions and external partners to ensure effective assessment and implementation of changes and CAPAs
Design, maintain, and continuously improve integrated processes for change management and deviation management, including SOPs, work instructions, templates, training materials, and workflows
Develop and deliver training programs and provide subject matter expertise to drive consistent application of quality processes across internal teams and external partners
Establish and maintain dashboards, KPIs, and trend analyses to monitor process performance, compliance, and effectiveness
Support management review activities by providing integrated quality metrics, trend analyses, and insights
Support the overall QMS framework to ensure compliance with FDA, EMA, ICH, and other global regulatory requirements
Serve as a subject matter expert during internal audits, external audits, and regulatory inspections related to change management and deviation/CAPA management processes
Qualification
Required
Bachelor's degree in Science, Engineering, Computer Systems, or related field (advanced degree preferred)
Minimum 8–10 years of experience in Quality Systems within the pharmaceutical or biotechnology industry
Demonstrated expertise in Change Control, Deviations, and CAPA management, including use of electronic QMS tools (preferably Veeva Quality Vault QMS)
Excellent analytical, root cause analysis, and problem-solving capabilities
Ability to influence and collaborate effectively across functions and organizational levels
Strong understanding of GxP regulations, FDA and EMA expectations, and ICH Q10 principles
Experience supporting late-stage development and/or commercial products in an outsourced manufacturing and testing model
Preferred
Experience leading governance forums and driving continuous improvement initiatives
Detail-oriented with the ability to balance compliance, efficiency, and business needs
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