Associate Director/Director, Data Governance

Role: Data Governance Associate Director/Director specializing in R&D data, AI oversight, and quality systems within biopharma. Objectives: establish and maintain data governance frameworks, oversee AI risk assessments, ensure compliance, and support regulatory readiness. Responsibilities: act as Process Owner for R&D Data and Records Integrity, manage inventory of R&D data and AI applications, conduct risk assessments, and ensure ongoing control of AI tools; lead data migration and digitization projects; advise cross-functional teams on data stewardship and responsible AI use; represent Quality Governance during inspections. Requirements: 7+ years (Associate Director) or 10+ years (Director) experience in GxP quality assurance, data integrity, or computerized systems in pharma/biotech; bachelor’s in science, engineering, or related field; deep knowledge of data integrity principles (ALCOA+), GMP/GCP/GLP regulations, and AI/ML risk concepts; proven experience with data governance artifacts, system validation, and cross-functional project leadership; strong communication skills. High-Value: focus on R&D data, AI oversight, data integrity, GxP compliance, cross-functional collaboration, and regulatory inspection readiness. Work setup: hybrid in NYC, Boston, Research Triangle (NC), or SF Bay Area; 3 days/week in-office; minimal travel.