Director, Quality Data Governance & Technology

Director Of Quality, Data Governance & Technology

As Director of Quality, Data Governance & Technology, you will lead enterprise-wide CSV oversight and drive the Data Governance and Data Integrity program. You'll partner with cross-functional teams to ensure compliant, AI-aware quality systems and data practices that scale with BioMarin's growing digital initiatives. You'll shape how AI, automation, and analytics improve quality outcomes while maintaining regulatory excellence. This role blends strategic leadership with hands-on program execution to advance BioMarin's data-centric quality landscape. You will influence senior stakeholders and act as a bridge between Quality, IT, and DTA to enable responsible, transformative technology use.

Responsibilities

• Provide leadership for Quality Engineers overseeing CSV activities across enterprise systems
• Co-lead continuous improvement of the CSV program with harmonized QMS and lifecycle approaches
• Evolve CSV execution for AI-enabled systems and AI-assisted validation tools
• Ensure CSV/CSA activities align with DTA policies and System Development Lifecycle risk-based approaches
• Establish global CSV KPIs and report compliance issues to management
• Lead Data Governance and Data Integrity program, designing a comprehensive governance framework
• Develop and maintain a Data Governance Master Plan with cross-functional collaboration
• Define deliverables to enable data integrity by design across business processes
• Implement training for data governance and data integrity across BioMarin
• Lead digital transformation efforts in Quality, including AI strategy and pilot deployments
• Foster cross-functional collaboration to standardize quality policies and procedures across the network
• Develop and mentor a high-performing team in CSV, data governance, and AI competencies
• Drive a standardized yet flexible approach to CSV and data governance globally

Key requirements

• 15+ years in biotechnology/pharma or a highly regulated industry
• Extensive GMP/GDP knowledge and experience
• 8+ years of management experience with mentoring and staff development
• Strong data analytics, digital tools, and AI experience a plus
• Proven ability to communicate with and influence senior stakeholders and inspectors
• Ability to work effectively in a matrix organization and drive results through influence
• Excellent interpersonal skills and ability to defend approaches to senior management
• Onsite at HQ preferred (San Rafael, CA) but open to virtual
• Collaboration
• Leadership
• Stakeholder management
• Computer System Validation (CSV)
• Data Governance
• Data Integrity