Director/Senior Director, Data Governance

The role

This role builds and maintains the data governance framework for R&D data and AI oversight. The person will serve as Process Owner for R&D Data and Records Integrity and Business Owner for key quality technology systems.

What you will do

• Serve as Process Owner for R&D Data and Records Integrity and Business Owner for Veeva Quality Docs and DocuSign Part 11
• Own and maintain the R&D data governance framework and associated risk assessments
• Apply risk assessments and control strategies to computerized systems and AI tools
• Maintain the inventory of AI applications in use across R&D and provide ongoing AI oversight
• Advise R&D teams on data stewardship, data quality, and responsible AI adoption
• Drive strategy for large cross-functional data migration and digitization projects
• Establish guardrails for the use of AI in QMS process execution
• Contribute to the QA master audit schedule and vendor qualification program
• Oversee, review, and provide final approval for non-program-specific Quality Events, Investigations, and CAPAs
• Represent Quality Governance in regulatory inspections and third-party audits

Required qualifications

• 7+ years (Associate Director) or 10+ years (Director) of progressive GxP quality assurance, data integrity, or computerized systems compliance experience in pharmaceutical, biotech, or related regulat
• Bachelor's degree in a scientific, engineering, information systems, or related discipline
• Strong working knowledge of data integrity principles (e.g., ALCOA+) and applicable GMP, GCP, and/or GLP regulations
• Demonstrated experience with computer system assurance/validation
• Working knowledge of AI/ML risk concepts including model validation, bias, explainability, and drift monitoring
• Demonstrated experience building or maintaining data governance artifacts within an R&D setting
• Demonstrated experience serving as a Process Owner or System/Business Owner
• Experience leading or contributing substantively to cross-functional data migration, asset onboarding, or system change projects
• Strong cross-functional communication and collaboration skills
• Demonstrated ability to operate with a high degree of independence

Benefits

• Equity
• Comprehensive benefits
• Generous perks

Before you apply

• Please apply only if you reside in New York City metro area, Boston metro area, Research Triangle (NC), or San Francisco Bay Area or are willing to relocate

About the company

Formation Bio is a tech and AI driven pharma company that builds technology platforms, processes, and capabilities to accelerate drug development and clinical trials.