Formation Bio
Director/Senior Director, Data Governance
$186K–$232K
Boston, MA +3 · Director · Full-time · Posted Aug 24, 2026
- Location
- Boston, MA
New York, NY
116 Huntington Ave., Back Bay, Boston, MA, 02116
16 E 34th St., New York City, NY, 10016 - Experience
- 7+ years (Associate Director) or 10+ years (Director).
- Education
- Bachelor's degree in a scientific, engineering, information systems, or related discipline.
About the job
Owns R&D data governance and AI oversight, ensuring data, AI tools, and quality systems remain controlled and compliant; at Director level, also sets strategy and represents Quality Governance in regulatory inspections.
What you'll do
- Maintain the R&D data governance framework and AI application inventory, including risk assessments and oversight.
- Own key quality systems and drive cross-functional data migration and digitization initiatives.
- Support audits and inspections, approve non-program-specific Quality Events, Investigations, and CAPAs, and advise R&D on data governance and responsible AI.
What they ask for
- 7+ years (Associate Director) or 10+ years (Director) of progressive GxP quality assurance, data integrity, or computerized systems compliance experience in a regulated industry.
- Bachelor's degree in a scientific, engineering, information systems, or related discipline.
- Working knowledge of data integrity principles, applicable GMP/GCP/GLP regulations, computer system assurance/validation, and AI/ML risk concepts.
- Experience with R&D data governance artifacts and AI oversight, Process/System/Business Owner responsibilities, and cross-functional data migration or system change projects.
Pay
$185,500 - $232,000 (total compensation)
Tools
Veeva Quality Docs, DocuSign Part 11, ALCOA+
AI focus
Oversee AI applications used across R&D, conduct and approve AI risk assessments, monitor deployed models, and establish guardrails for AI use in QMS processes, with human accountability.
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