Associate Director, IS Quality and Compliance

Role: Associate Director, IS Quality and Compliance, leading GxP computerized system validation within the Information Sciences organization of a biopharma company focused on oncology and RAS-targeted therapies. Responsibilities: oversee CSV/CSA activities, ensure regulatory compliance, develop risk-based validation strategies, manage validation lifecycle deliverables, and lead audit-readiness initiatives. Lead and mentor validation teams, collaborate with cross-functional stakeholders including Quality and Business Owners, and continuously improve validation practices. Required: Bachelor's in Life Sciences, Engineering, or related; 12+ years supporting GxP computerized systems; expertise in CSV/CSA, data integrity, GxP regulations (FDA 21 CFR Part 11, EU Annex 11), and validation methodologies; experience managing complex validation programs and supporting inspections. Preferred: experience with cloud-based GxP systems, enterprise applications (e.g., Veeva, NetSuite), and leading multinational validation projects; familiarity with IT security standards like NIST and ISO 27001. HighValue: regulated GxP environment, computerized system lifecycle, audit and inspection support, cloud/SaaS validation, and cross-region leadership. WorkSetup: onsite at Redwood City, CA, with salary range $186K-$233K; travel expectations not specified.