Director, Quality Data Governance & Technology

Role: Senior leader overseeing enterprise-wide Quality Data Governance, Computer System Validation (CSV), and digital transformation initiatives within BioMarin’s Technical Operations, with a focus on AI and data integrity. Responsibilities: lead and develop teams managing CSV programs, standardize validation methodologies, and evolve processes to incorporate AI-enabled validation tools; establish and improve global data governance and integrity programs, ensuring compliance and best practices; drive digital and AI strategies by partnering with IT, Data Science, and stakeholders to pilot and scale emerging technologies; develop quality policies, collaborate cross-functionally across manufacturing, engineering, QC, QA, and compliance, and support regulatory inspections. Requirements: 15+ years in biotech/pharma/medical device industries, with deep knowledge of GMP/GDP regulations, data governance, and CSV; 8+ years of management experience with proven team development skills; advanced degree in Data Science, Computer Science, Engineering, or Life Sciences preferred. High-Value: extensive expertise in computer system validation, data integrity, data governance, GMP compliance, and digital/AI technologies; experience leading digital transformation and advanced analytics in regulated environments. Work Setup: primarily onsite at San Rafael, CA, with openness to virtual work.