Associate Director/Director, Digital Quality

Formation Bio•Boston, NY

5d•Hybrid

About The Position

The Digital Quality Associate Director/Director is a critical member of the Quality Governance team, with a primary focus on data governance and AI oversight across Formation Bio's R&D organization. This role serves as Process Owner for R&D Data and Records Integrity and as Business Owner for key quality technology systems (Veeva Quality Docs, DocuSign Part 11), and owns the organization's inventory of R&D data and AI applications, along with their associated risk assessments. Reporting directly to the Head of Quality with no intermediate management layer, this role builds and maintains the data governance framework that governs how R&D data is stewarded, sourced, and controlled, and performs and approves AI risk assessments and oversight activities for AI tools used across R&D, ensuring appropriate guardrails, human review, and accountability. This role also drives cross-functional R&D data migration and digitization initiatives and ensures R&D data, AI tools, and computerized systems remain in a continued state of control and compliance with Formation Bio standards and applicable regulations. At the Director level, this role also sets R&D data governance and AI oversight strategy and represents Quality Governance during regulatory inspections.

Requirements

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 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 as they pertain to data, records, and computerized systems
Demonstrated experience with computer system assurance/validation, including risk-based approaches to initial context of use, change in context of use, and functionality changes
Working knowledge of AI/ML risk concepts—including model validation, bias, explainability, and drift monitoring—sufficient to design and approve AI risk assessments and mitigation strategies
Demonstrated experience building or maintaining data governance artifacts within an R&D setting—such as data inventories, data stewardship models, retention schedules, and access control frameworks—and overseeing AI applications used in R&D processes
Demonstrated experience serving as a Process Owner or System/Business Owner, including SOP governance, KPI monitoring, and change control management
Experience leading or contributing substantively to cross-functional data migration, asset onboarding, or system change projects
Strong cross-functional communication and collaboration skills, with experience representing Quality Assurance in working groups, inspections, or regulatory interactions
Demonstrated ability to operate with a high degree of independence, exercising sound judgment in a role reporting directly to the 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, ensuring these processes and systems remain accurate, current, and effective
Own and maintain the R&D data governance framework, including the inventory of R&D data (categories, stewards/owners, source of truth, retention requirements, and access controls) 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, including periodic review of deployed models to assure a continued state of control, compliance, and appropriate human accountability
Serve as a key R&D partner on data governance matters, advising R&D teams on data stewardship, data quality, and responsible AI adoption in day-to-day R&D workflows
Own and drive strategy for large cross-functional data migration and digitization projects, including asset onboarding/acquisition and system changes
Establish guardrails, in partnership with Operational Excellence, for the use of AI in QMS process execution (e.g., AI-assisted investigation drafting, CAPA analysis, audit preparation)
Contribute to and support the QA master audit schedule and vendor qualification program, including evaluating vendors' use of AI or other automated systems in GxP-impacting work
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, and support inspection readiness activities
Partner cross-functionally with R&D, IT, and Operational Excellence to embed Quality by Design principles into data, AI, and systems governance