Director, R&D Data Governance & AI Oversight (Hybrid)

Formation; Boston (MA); Hybrid; USD 162,000 - 202,000; Full time

Benefits offered by this job

Equity

Comprehensive benefits

Hybrid work model

Job summary

Formation Bio is seeking a Digital Quality Associate Director/Director to join the Quality Governance team, focusing on data governance and AI oversight across R&D, owning data/inventory and AI risk assessments.

Reporting to Head of Quality with no intermediate management, you will build and maintain the governance framework, ensure AI tools remain in control, and drive cross-functional data migration and digitization.

Qualifications

• 7+ or 10+ years of GxP QA, data integrity, or computerized systems experience.
• Strong knowledge of ALCOA+ data integrity principles and GMP/GCP/GLP rules.
• Experience with risk-based validation for computerized systems and AI tools.

Responsibilities

• Serve as Process Owner for R&D Data and Records Integrity and for Veeva Quality Docs.
• Maintain the R&D data governance framework and risk assessments.
• Apply risk controls for initial context of use and changes to systems/AI tools.
• Maintain AI application inventory and provide ongoing oversight.
• Advise R&D teams on data stewardship and responsible AI adoption.
• Drive cross-functional data migration and digitization projects.
• Establish guardrails for AI use in QMS processes (CAPA, investigations).
• Support QA master audit schedule and vendor qualification, incl. AI use.
• Oversee Quality Events, Investigations, CAPAs; prepare for inspections.
• Represent Quality Governance in regulatory inspections and audits.

Skills

GxP quality assurance

Data integrity

Computerized systems compliance

AI/ML risk concepts

Cross-functional collaboration

Data governance

Education

Bachelor’s degree in science/engineering/IS

Tools

Veeva Quality Docs

DocuSign Part 11

Job description

Formation Bio is seeking a Digital Quality Associate Director/Director to join the Quality Governance team, focusing on data governance and AI oversight across R&D, owning data/inventory and AI risk assessments.

Reporting to Head of Quality with no intermediate management, you will build and maintain the governance framework, ensure AI tools remain in control, and drive cross-functional data migration and digitization.