Associate Director, IS Quality and Compliance

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: Revolution Medicines is seeking an experienced leader with a pharmaceutical quality assurance and Computer System Validation background to serve as Associate Director, IS Quality and Compliance within the Information Sciences organization.

This hands-on leadership role is responsible for the operational leadership and oversight of GxP computerized system compliance across Information Sciences. The Associate Director will lead and mature risk-based Computer Software Assurance practices, oversee a portfolio of complex validation initiatives, develop team members and external resources, and partner with Quality and business stakeholders to maintain inspection readiness and regulatory compliance.

This position reports to the Senior Director, IS Quality, Risk & Compliance. Responsibilities: Lead the day-to-day IS Computer System Validation (CSV) program, translating departmental direction into operating priorities, execution plans, and measurable outcomes. Serve as the primary IS technical and operational lead for CSV, CSA, data integrity, electronic records and signatures, and computerized system lifecycle compliance.

Provide leadership and oversight for CSV/CSA activities across GxP computerized systems, ensuring validation strategies align with regulatory requirements, business objectives, approved policies, and industry practices. Interpret and provide practical guidance on GxP regulations and industry standards related to computerized systems, electronic records, electronic signatures, and data integrity. Escalate significant risks or policy decisions to the Senior Director.

Direct project teams in developing risk-based validation approaches and system implementation strategies for enterprise applications, cloud and SaaS solutions, infrastructure, integrations, data migrations, and system retirements. Lead and mentor employees, consultants, and project resources supporting CSV and computerized system compliance. Coordinate workloads, establish delivery expectations, and provide technical coaching and feedback.

Partner with IS, System Owners, Business Owners, Business Process Owners, and Quality to assess compliance requirements and ensure validation activities are appropriately planned, resourced, and executed. Oversee the development, review, and approval of validation lifecycle deliverables, including validation plans, risk assessments, requirements, testing documentation, traceability, reports, data migration documentation, periodic reviews, and system retirement documentation.

Lead the development and continuous improvement of CSV procedures, templates, training, and lifecycle methodologies within the approved quality-management framework. Provide operational oversight for CSV-related deviations, investigations, CAPAs, change controls, and periodic reviews. Ensure timely closure, assess effectiveness, and escalate significant compliance concerns. Oversee data integrity assessments, audit-trail reviews, access-control reviews, and electronic-signature assessments to ensure compliance with ALCOA+ principles and regulatory expectations.

Lead cross-functional initiatives to strengthen risk-based validation practic