R&D Data & AI Governance Director

Socket.dev; 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 lead data governance and AI oversight across its R&D organization. This role acts as Process Owner for R&D Data and Records Integrity and as Business Owner for Veeva Quality Docs and DocuSign Part 11, managing AI risk assessments and governance across R&D tools and systems.

Reporting to the Head of Quality with no intermediate layer, you will drive data migration, AI risk management, and cross-functional governance to

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 regulated industry
• Bachelor's degree in scientific, engineering, information systems, or related discipline
• Strong knowledge of data integrity principles (ALCOA+) and GMP, GCP, GLP regulations as they pertain to data, records, and computerized systems
• Experience with computer system assurance/validation, including risk-based approaches to initial context of use, changes in context of use, and functionality changes
• Knowledge of AI/ML risk concepts—validation, bias, explainability, drift monitoring—enough to design and approve AI risk assessments and mitigation strategies
• Experience building data governance artifacts within an R&D setting and overseeing AI applications used in R&D processes
• Experience serving as a Process Owner or System/Business Owner, including SOP governance, KPI monitoring, and change control management
• Experience leading cross-functional data migration, asset onboarding, or system changes
• Strong cross-functional communication and collaboration skills, with regulatory interaction experience
• Ability to operate independently reporting to Head of Quality with no intermediate management layer

Responsibilities

• 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 risk assessments
• Apply risk assessments and control strategies to initial context of use and changes in context for 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 in day-to-day workflows
• Lead data migration and digitization projects across cross-functional teams
• Establish guardrails for AI use in QMS processes with Operational Excellence
• Contribute to QA master audit schedule and vendor qualification, evaluating AI usage
• Oversee and approve non-program-specific Quality Events, Investigations, and CAPAs
• Represent Quality Governance in regulatory inspections and third-party audits
• Partner with R&D, IT, and Operational Excellence to embed Quality by Design in data, AI, and systems governance

Skills

Quality assurance

Data integrity

Computerized systems

GxP regulations

AI risk concepts

Data governance

Cross-functional collaboration

Independent work

Regulatory inspections

SOP governance

Education

Bachelor's degree

Tools

Veeva Quality Docs

DocuSign Part 11

Job description

Formation Bio is seeking a Digital Quality Associate Director/Director to lead data governance and AI oversight across its R&D organization. This role acts as Process Owner for R&D Data and Records Integrity and as Business Owner for Veeva Quality Docs and DocuSign Part 11, managing AI risk assessments and governance across R&D tools and systems.

Reporting to the Head of Quality with no intermediate layer, you will drive data migration, AI risk management, and cross-functional governance to