[Hiring] Executive Director, Quality, Europe @Revolution Medicines

Role Description

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
• External partners

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 indicators 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.

Qualifications

• Degree in Life Sciences, Pharmacy, Chemistry, or related field (PhD, PharmD, or MSc preferred).
• 20+ years of GxP Quality experience 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).

Requirements

• Biotech experience.
• Significant leadership experience, including managing regional or global teams.

Company Description

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 currently in clinical development include:

• 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
• RMC-5127, a RAS(ON) G12V-selective inhibitor

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.