Director, Quality Data Governance & Technology

Responsibilities:
- Lead and provide direction for Quality Engineers overseeing enterprise computer software validation (CSV) activities; ensure resourcing for an established project portfolio.
- Continuously improve the CSV program (methodologies, requirements, lifecycle approach) and evolve execution for increasing AI-enabled validation.
- Ensure CSV/CSA activities are aligned and streamlined using an appropriate System Development Lifecycle approach based on complexity, risk, and intended use.
- Define global CSV KPIs, trend performance metrics, support Quality Management Review, and report/escalate compliance issues.
- Partner with Compliance on global/site quality inspections and provide SME support and response to observations.
- Develop, own, and continuously improve a compliant Data Governance/Data Integrity program; implement governance via a Data Governance Master Plan.
- Define and deliver data governance measures to enable data integrity by-design; optimize policies/procedures and standardize within a simplified QMS.
- Implement and maintain training and establish a governance structure with matrix site/functional representatives.
- Support digital/AI strategy for Quality: identify/evaluate/pilot AI, machine learning, automation, and analytics; integrate QMS/enterprise data for data-driven decisions.
- Champion responsible AI tool deployment with governance, human-in-the-loop controls, and evidence-based KPIs.
- Develop, implement, and communicate quality policies/procedures; collaborate across Engineering, Manufacturing, QC/QA, Compliance, IT, and Data Science.
- Lead, coach, and develop the Quality team; foster continuous improvement, compliance, and innovation.

Qualifications & Preferred Skills:
- Education: Bachelor’s or advanced degree (preferred) in Data Science, Computer Science, Engineering (Chemical Engineering/Biotech or related), or Life Sciences.
- Experience: 15+ years in biotech/pharma/medical device or similarly regulated industry; 8+ years management experience.
- Extensive GMP/GDP knowledge; strong CSV, data integrity, and data governance expertise.
- Demonstrated use of data/analytics/digital tools to improve quality outcomes; AI-enabled solution experience is a strong plus.
- Strong leadership, stakeholder management, matrix leadership, and ability to present data to senior management/inspectors.

Workstyle:
- Prefer onsite at Headquarters, San Rafael, CA; virtual employees may be considered.