revolutionmedicines · Redwood City, California, United States
Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS. Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide. Our people are united by a shared way of working: follow the science, challenge assumptions, act with urgency and hold ourselves to a high standard of rigor—all in service of patients. The Opportunity: Lead GxP internal audits and external audits including completing audit reports and follow-up on corrective actions. Maintain the internal/external audit schedules. Assure GMP/GxP compliance with suppliers. Oversight of all aspects of GxP vendor / supplier program management to ensure compliance with GxP regulations and RevMed internal standards. Demonstrate the ability to multi-tack. Prioritize work and independently solve problems. Collaborate with vendors and internal teams to draft and complete Quality Agreements. Perform Risk Assessments, qualifications, and monitor Suppliers/CMOs. Collaborate with cross-functional teams and represent Quality Vendor Management at meetings. Create and implement any tools to improve compliance, consistency, and efficiency for GMP/GXP auditing and Vendor management. Provide support preparation of anticipated regulatory inspections (including those at contracted organizations), and partner audits with cross-functional teams. Maintain supplier management program, ensuring requirements, plans, processes, metrics, and tracking system for GxP suppliers are established and followed. Responsible for qualifications of GMP suppliers inc…
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