Director, Quality Data Governance & AI-Driven CSV

BioMarin Pharmaceutical Inc.

San Rafael (CA)

On-site

USD 180,000 - 240,000

Full time

5 days ago

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Job summary

BioMarin Pharmaceutical Inc. seeks a senior leader to drive enterprise CSV quality oversight, data governance, and digital/AI initiatives within the Quality organization. You will partner with IT, Data Science, and manufacturing to ensure compliant, scalable data governance and AI-enabled validation practices.

The role emphasizes leadership, regulatory excellence, and cross-functional collaboration to advance BioMarin's data governance maturity and AI-enabled capabilities across global sites.

Qualifications

15+ years in biotech/pharma or regulated industry.
Strong knowledge of GMP/GDP and quality systems.
Experience leading cross-functional teams across CSV, data governance, and digital
Proven ability to drive data-driven quality improvements and AI-related initiatives.

Responsibilities

Provide CSV quality oversight for enterprise IT systems and applications.
Lead Data Governance and Data Integrity programs across BioMarin.
Shape and implement digital transformation and AI strategies in Quality.
Collaborate across engineering, manufacturing, QC, QA, Compliance, IT and Data Science.
Develop leaders; foster continuous improvement and standardized CSV/data governance practices.

Skills

CSV/QA Leadership

Data Governance

AI/ML awareness

Regulatory Compliance

Stakeholder Management

Education

Bachelor's or higher in Data Science/CS/Engineering/Life Sciences

Job description

The role emphasizes leadership, regulatory excellence, and cross-functional collaboration to advance BioMarin's data governance maturity and AI-enabled capabilities across global sites.

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