Senior Manager, Quality Systems - Product Complaints & Shipment Excursions

Revolution Medicines•Redwood City, CA

6h•Hybrid

About The Position

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.

Requirements

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.

Nice To Haves

Strong organizational, project management, and prioritization skills.
Experience in both virtual sponsor and scaling global organization models.

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.