Associate Director, Electronic Systems Quality Assurance

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:

• Provide Global Quality oversight for GxP computerized systems, ensuring compliant implementation and lifecycle management across GMP, GCP, GLP, GVP, and GDP environments.

• Provide strategic quality eadership for Computerized System Validation (CSV) and Computer Software Assurance (CSA), including risk-based validation approaches, system changes, upgrades, integrations, data migrations, and periodic reviews.

• Lead, develop, and mentor the team, providing strategic direction and ensuring effective execution of CSV/CSA, Quality platform oversight, AI implementation, and digital compliance priorities.

• Own Quality oversight and governance of enterprise Quality digital platforms, including Veeva Vault and other GxP qualiy applications, ensuring platforms remain validated, inspection-ready, scalable, and fit for intended use.

• Establish and maintain digital Quality governance, including system ownership, change/release management, vendor oversight, access controls, audit trails, electronic records/signatures, and data integrity requirements.

• Lead Quality governance and implementation of Artificial Intelligence (AI) and emerging technologies within GxP processes, including generative AI, AI agents, machine learning, and intelligent automation.

• Develop risk-based frameworks for AI qualification, validation/assurance, change management, and ongoing monitoring in alignment with evolving regulatory expectations.

• Partner with Quality, Information Science, Clinical teams, Regulatory, Pharmacovigilance, PDM and other business functions to develop and execute the digital Quality roadmap and identify opportunities for compliant automation and process optimization.

• Serve as the Digital Systems QA SME for regulatory inspections and audits, maintaining inspection readiness and monitoring evolving FDA, EMA, PMDA, GAMP 5, 21 CFR Part 11, EU Annex 11, data integrity, CSA, and AI-related regulatory expectations.