Formation Bio is seeking an Associate Director/Director, Digital Quality to join their Quality Governance team. The successful candidate will serve as Process Owner for R&D Data and Records Integrity and as Business Owner for key quality technology systems.
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, including the inventory of R&D data and associated risk assessments
- Apply risk assessments and control strategies to initial context of use, changes in context of use, and functionality changes for computerized systems and AI tools
- Maintain the inventory of AI applications in use across R&D and provide ongoing AI oversight
- Serve as a key R&D partner on data governance matters, advising R&D teams on data stewardship, data quality, and responsible AI adoption
- Own and drive strategy for large cross-functional data migration and digitization projects
- Establish guardrails for the use of AI in QMS process execution
- Contribute to and support 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
Requirements:
- 7+ years (Associate Director) or 10+ years (Director) of progressive GxP quality assurance, data integrity, or computerized systems compliance experience
- Bachelor's degree in a scientific, engineering, information systems, or related discipline
- Strong working knowledge of data integrity principles and applicable GMP, GCP, and/or GLP regulations
- Demonstrated experience with computer system assurance/validation, including risk-based approaches
- 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
Total Compensation Range: $161,500 – $202,000
