Senior Manager, Clinical Quality Assurance, Japan

Revolution Medicines is a global, commercial-stage oncology company developing RAS(ON) inhibitor therapies for RAS-addicted cancers. The Senior Manager, Clinical QA serves as the company's Japan quality lead for GCP, GVP, and GPSP oversight, partnering with Clinical Development, Pharmacovigilance, Regulatory Affairs, and external vendors to ensure compliance with Japanese regulatory requirements. Responsibilities span GCP quality assurance (leading inspections and inspection readiness, auditing CROs and clinical vendors, supporting deviation and CAPA management), GVP quality oversight of post-marketing surveillance activities under GPSP, and building out the Japan Quality Management System. Requires a bachelor's degree in a life-science field and at least 3 years of GCP/GVP/GPSP quality assurance experience in the pharmaceutical industry, with experience supporting regulatory inspections and overseeing CROs and pharmacovigilance vendors.