Director, CSV, Quality Data Governance & AI

BioSpace; San Rafael (CA); On-site; USD 240,000 - 360,000; Full time

Job summary

BioMarin in San Rafael, CA seeks a Director of Quality, Data Governance & Technology to lead enterprise CSV quality oversight and data governance programs. The role partners with DTA to advance AI and digital initiatives while ensuring regulatory compliance across global Quality processes.

The candidate will drive cross-functional collaboration, develop global KPIs, and mentor a team of Quality Engineers to execute validated, compliant systems leveraging AI-enabled tools as they mature.

Qualifications

• 15+ years of experience in Biotechnology or a highly regulated industry.
• 8+ years of management experience leading teams.
• Strong knowledge of GMP and GDP regulations.
• Experience applying data governance, data integrity, and AI-enabled solutions.

Responsibilities

• Lead CSV quality oversight and program leadership for enterprise-wide systems.
• Develop and continuously improve Data Governance / Data Integrity programs.
• Drive digital transformation and AI strategy within Quality and IT.
• Collaborate across engineering, manufacturing, QC, QA, Compliance, and IT.

Skills

Leadership

Quality Management

Data Governance

CSV/CSV Validation

Data Integrity

AI / Digital Transformation

Stakeholder Management

Regulatory Compliance

Cross-Functional Collaboration

Education

Bachelor's or advanced degree in Life Sciences / Engineering / Computer Science

Advanced degree preferred

Job description

BioMarin in San Rafael, CA seeks a Director of Quality, Data Governance & Technology to lead enterprise CSV quality oversight and data governance programs. The role partners with DTA to advance AI and digital initiatives while ensuring regulatory compliance across global Quality processes.

The candidate will drive cross-functional collaboration, develop global KPIs, and mentor a team of Quality Engineers to execute validated, compliant systems leveraging AI-enabled tools as they mature.