Senior Manager, Quality Systems - Product Complaints & Shipment Excursions at Revolution Medicines

Redwood City, California, United States -

Full Time

Start Date

Immediate

Expiry Date

22 Apr, 26

Salary

205000.0

Posted On

22 Jan, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Systems, Product Complaints, Shipment Excursions, GMP Manufacturing, Analytical Skills, Problem-Solving, GxP Regulations, FDA Expectations, EMA Expectations, ICH Q10 Principles, Cross-Functional Collaboration, Training, Risk Assessment, CAPAs, Change Controls, Regulatory Reporting

Industry

Hospitals and Health Care

Description

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Opportunity: 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. Required Skills, Experience and Education: 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 Skills: Strong organizational, project management, and prioritization skills. Experience in both virtual sponsor and scaling global organization models. #LI-Hybrid #LI-JC1 The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training. Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities. Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status. Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com. Base Pay Salary Range $164,000—$205,000 USD

Responsibilities

Oversee and manage clinical and commercial Product Complaints and Temperature/Shipment Excursions within the Quality Management System. Lead investigations and coordinate cross-functional support to ensure compliant resolution of complaints and excursions.