Associate Director, IS Quality and Compliance
Revolution Medicines - San Francisco Bay Area
Hiring: Associate Director, IS Quality and Compliance Company: Revolution Medicines Location: San Francisco Bay Area Job Posted Time: 2026-09-10 11:48:19 Employment Type: Full-time Target Skills & Keywords : GDPR, HIPAA, NetSuite, Quality Assurance, Regulatory Compliance, Risk Management, SOC 2, SaaS About the job Experience: •12 years of progressive experience supporting GxP computerized systems in the pharmaceutical or biotechnology industry. •Minimum 12 years of progressive experience supporting GxP computerized systems in the pharmaceutical or biotechnology industry. Required Skills: •This position reports to the Senior Director, IS Quality, Risk & Compliance. •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. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!