Director, R&D Data & AI Governance

Formation Bio; Town of Boston (NY); Hybrid; USD 162,000 - 202,000; Full time

Job summary

Formation Bio seeks a Digital Quality Associate Director/Director to lead data governance and AI oversight within R&D, owning data integrity processes and QA systems such as Veeva Quality Docs and DocuSign Part 11.

Reporting to the Head of Quality, you will build the data governance framework, perform AI risk assessments, oversee AI tools, and drive cross‑functional data migration and digitization initiatives in a regulated, GxP environment.

Qualifications

• 7+ years (Associate Director) or 10+ years (Director) of QA, data integrity, or computerized systems in pharma/biotech
• Strong knowledge of ALCOA+ and GMP/GCP/GLP as they pertain to data and systems
• Experience in computer system assurance/validation with risk-based approaches
• Working knowledge of AI/ML risk concepts including model validation and drift monitoring
• Experience building data governance artifacts and overseeing AI applications in R&D processes

Responsibilities

• Serve as Process Owner for R&D Data and Records Integrity and Business Owner for Veeva Quality Docs & DocuSign Part 11
• Maintain the R&D data governance framework and risk assessments
• Apply risk-based approaches to changes in context of use for computerized systems & AI tools
• Oversee AI tool inventory and perform ongoing AI oversight and reviews
• Partner with R&D, IT, and Operational Excellence to embed Quality by Design in data and AI governance
• Lead cross-functional data migration and digitization projects
• Establish guardrails for AI in QMS process execution
• Support QA master audit schedule and vendor qualification including AI usage in GxP work
• Oversee and approve non-program-specific quality events and CAPAs
• Represent Quality Governance in inspections & audits
• Support inspection readiness and collaborate on regulatory interactions

Skills

Data governance

AI risk

Regulatory compliance

Cross-functional collaboration

GxP knowledge

Education

Bachelor's degree in science/engineering/IT

Job description

Formation Bio seeks a Digital Quality Associate Director/Director to lead data governance and AI oversight within R&D, owning data integrity processes and QA systems such as Veeva Quality Docs and DocuSign Part 11.

Reporting to the Head of Quality, you will build the data governance framework, perform AI risk assessments, oversee AI tools, and drive cross‑functional data migration and digitization initiatives in a regulated, GxP environment.