Chao-Hsiang Wu 吳朝翔
Director, Systems and Operations Group Lead at BioMarin
- Role
- Director, Systems & Operations, Analytical Sciences at BioMarin Pharmaceutical Inc.
- Location
- Thousand Oaks, CA, US
- LinkedIn followers
- 500 followers
About Chao-Hsiang Wu 吳朝翔
Director of Systems & Operations and Certified Operational Excellence Professional (OEP) with over 20 years of experience transforming biotech operations through digital innovation and strategic leadership. Proven track record of bridging Analytical Sciences with business goals, currently driving AI adoption strategies (LLM, predictive modeling) and data governance frameworks to enhance decision-making and compliance. Expert in optimizing infrastructure and leading cross-functional teams to deliver scalable, GxP-compliant solutions that reduce risk, accelerate drug development timelines, and maximize business value.
Experience
Director, Systems & Operations, Analytical Sciences
Sep 2023 — Present
Leads the Systems & Operations (S&O) group, providing the critical operational, compliance, and logistical backbone for the Analytical Sciences (AS) department.Delivers tangible business value by steering the S&O group to directly support and enable AS’s strategic objectives across People, Innovation & Growth, and Value Commitment pillars.Enhances operational agility and consistency by developing and implementing standardized processes and guidelines for QMS, method development, and project management.Mitigates business risk by proactively identifying and managing risks related to critical reagents, GxP compliance, data integrity, CSA/CSV, analytical instrument IOPQ, and project execution.Drives operational efficiency through process standardization, disciplined project management, and resource optimization, while maintaining robust regulatory compliance.AI, Data Science & Quality InitiativesSpearheaded AS department Data Integrity Risk Assessment (DIRA) awareness and implemented data verification workflows (DV tables) to broader TDS organization to enhance data integrity and audit readiness.Developed 2026 AI adoption strategy for AS department, collaborated with SMEs to focus on LLM AI agents for regulatory filings/compliance audits and digital tools for predictive modeling and resource forecasting. Proposed automated technical report authoring to optimize SME strategic bandwidth.Applied Lean Six Sigma and BPM (Business Process Management) lean principles to AS operations. Pursuing PMI-CPMAI (Certified Professional in Managing AI) certification to lead AI/ML-driven quality initiatives and to ensuring data integrity, rigorous governance, compliance, and sustained business value from AI initiatives.Drove AS-Quality RACI workshops to define method lifecycle transitions. Promoted method development BPD and method qualification SOP to ensure readiness for Quality organization.
Education
University of Washington
Ph.D., Analytical Chemistry
1998 — 2003
Soochow University
Bachelor of Science - BS, Chemistry
1989 — 1993
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