Revolution Medicines · 14 hours ago
Senior Manager, Quality Systems - Product Complaints & Shipment Excursions
San Francisco Bay Area
Full-time
Hybrid
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 for RAS-addicted cancers. The Senior Manager, Quality Systems will oversee and manage product complaints and shipment excursions, ensuring compliance and continuous improvement within the Quality Management System.
Health CareLife ScienceMedical
Responsibilities
Provide day-to-day oversight and management of clinical and commercial Product Complaints and Temperature/Shipment Excursions, ensuring consistent, compliant execution and continuous monitoring including improvement of these processes within the Quality Management System (QMS)
Own the end-to-end lifecycle for complaints and excursions, including intake, triage, investigation, escalation, impact assessment, documentation, and timely closure in accordance with regulatory and internal requirements
Lead and perform assessments and investigations, coordinating cross-functional support from internal teams and external partners to ensure timely, thorough, and compliant resolution
Partner with Pharmacovigilance/Safety, Regulatory Affairs, Manufacturing, Quality Control, and Supply Chain to ensure appropriate escalation, investigation, and regulatory alignment
Ensure risk-based evaluation and linkage of complaints and excursions to deviations, CAPAs, change controls, and regulatory reporting (e.g., Field Alerts), as applicable
Design, maintain, and continuously improve the Product Complaints and Shipment Excursions processes, including SOPs, work instructions, workflows, templates, training materials, and system configurations
Drive metrics, trending, and signal detection to identify emerging quality risks, patient impact, and systemic issues, and recommend corrective and preventive actions
Provide hands-on SME support, training, and guidance to internal teams and external partners to promote consistent and compliant handling practices
Support management review and quality governance forums by presenting summaries, trends, and risk assessments
Act as SME for internal audits, external audits, and regulatory inspections, ensuring inspection readiness across the product lifecycle
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
Demonstrate expertise in Product Complaints management and Shipment Excursions and electronic QMS tools (preferably Veeva Quality Vault)
Experience with GMP manufacturing investigations, working cross-functionally with internal stakeholders and external partners
Excellent analytical, investigation, and problem-solving capabilities
Strong understanding of GxP regulations, FDA and EMA expectations for product complaints, and ICH Q10 principles
Experience supporting late-stage development and/or commercial products in an outsourced manufacturing and testing model
Preferred
Strong organizational, project management, and prioritization skills
Experience in both virtual sponsor and scaling global organization models
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