Executive Director, Quality, Europe at Revolution Medicines

Netherlands

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Opportunity: The Executive Director, Head of Quality, Europe is responsible for leading and overseeing all Quality functions across the European region, ensuring compliance with European regulatory requirements. This role provides strategic and operational leadership across GxP Quality (GMP, GDP, GCP as applicable). In addition, this role serves as the key Quality representative for Europe, partnering closely with Regulatory Affairs, Manufacturing, Supply Chain, Clinical Operations, and external partners to ensure a robust and inspection-ready quality system. Key Responsibilities: Lead and develop the European Quality organization, ensuring alignment with global quality strategy and supporting the transition from clinical to commercial operations. Act as the primary Quality representative for Europe, providing leadership in regional and global governance forums and serving as the main interface with European regulatory authorities (e.g., EMA, national agencies). Ensure Quality oversight of MAH responsibilities, including lifecycle management, product complaints, recalls, and fulfillment of regulatory commitments in close collaboration with Regulatory Affairs. Establish, implement, and maintain an effective EU Quality Management System (QMS) in compliance with EU GMP, GDP, GCP (as applicable), and ICH guidelines. Participate in cross-functional review of Global SOPs, ensuring timely harmonization and effective implementation within the EMEA region. Oversee key quality system processes, including deviations, CAPAs, change control, risk management, product quality complaints, and document management. Monitor QMS performance through KPIs, risk indictors and management review process. Review quality agreements to ensure compliance with EU GMP, GDP and other regulatory requirements across the supply chain. Define and oversee the EU QP framework, ensuring compliant batch certification and appropriate governance of internal and/or contracted QPs. Ensure full compliance with EU GDP requirements, including oversight of distribution activities, wholesale authorizations, and Responsible Person (RP) functions within the EU supply network. Provide end-to-end Quality oversight of external partners (e.g., CMOs, 3PLs, distributors), including quality agreements, performance monitoring, and risk-based governance. Lead inspection readiness across Europe and manage regulatory inspections and internal/external audits, ensuring consistent positioning and effective interaction with authorities. Support regulatory submissions and lifecycle activities by ensuring quality oversight of relevant documentation and CMC components. Provide Quality leadership for new product introductions, technology transfers, and commercial launches in Europe, ensuring readiness of systems, processes, and partners. Collaborate cross-functionally with Regulatory Affairs, Technical Operations, Supply Chain, Clinical Operations, and Global Supplier Quality to ensure integrated and compliant execution across the product lifecycle. Drive a strong, proactive quality culture across all European operations, promoting continuous improvement and accountability. Required Skills, Experience and Education: Degree in Life Sciences, Pharmacy, Chemistry, or related field (PhD, PharmD, or MSc preferred). 20+ GxP Quality within the pharmaceutical industry. Track record of building and scaling Quality organizations. Track record of working in a GMP/GDP regulated environment. Deep knowledge of European regulatory requirements (EMA, EU GMP/GDP, ICH guidelines). Preferred Skills: Biotech experience. Significant leadership experience, including managing regional or global teams. 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. #LI-Remote #LI-LO1 We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message. Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @revmed.com email address. If you believe you’ve been contacted by someone impersonating a Revolution Medicines recruiter, please report it to careers@revmed.com so we can share these impersonations with our IT team for tracking and awareness.