Director/Senior Director, Data Governance

About Formation Bio Formation Bio is an AI-native pharma company differentiated by radically more efficient drug development. The company has built proprietary technology platforms to optimize critical aspects of clinical drug development, enabling more efficient trial design, faster trial completion, and higher quality trial data. Formation Bio acquires clinical-stage drugs from pharmaceutical and biotech companies with the goal to develop assets faster, unlock greater value per program and ultimately accelerate access to new treatments for patients. 2025 CNBC Disruptor 50 2025 Fierce 15 Award 2024 Endpoints 11 Award

Formation Bio

Bringing new treatments to patients faster and more efficiently.

F

formation.bio

51-200 employees

Biotechnology Research

New York, NY

2013

Privately Held

48k LinkedIn followers

Raised $528M

• Our Vision for AI in Pharma
• [https://www.formation.bio/blog/our-vision-for-ai-in-pharma]
• Our Current Drug Portfolio [https://www.formation.bio/licensing-and-pipeline]
• At Formation Bio, our values are the driving force behind our mission to
• revolutionize the pharma industry. Every team and individual at the company
• shares these same values, and every team and individual plays a key part in our
• mission to bring new treatments to patients faster and more efficiently.
• 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
• 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

• 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

• Compensation Individual compensation is determined by several factors, including
• role scope, geographic location, and skills & experience. Your offer will
• reflect where you fall within the range based on these considerations. In
• addition to base salary, we offer equity, comprehensive benefits, and generous
• perks. If the posted range doesn't match your expectations, we still encourage
• you to apply!
• Where We Hire Formation Bio is prioritizing hiring in key hubs, primarily the
• New York City and Boston metro areas, with a hybrid model requiring 3 days per
• week in office. Applicants from the Research Triangle (NC) and San Francisco Bay
• Area may also be considered. Please apply only if you reside in these locations
• or are willing to relocate.
• Equal Opportunity Formation Bio is committed to building a diverse and inclusive
• We've seen a rise in recruiting impersonation scams across the industry, where
• fake profiles pose as recruiters aiming to trick candidates into sharing
• personal and financial information through illegitimate interviews and job
• offers. All legitimate recruiting communications from Formation Bio will come
• from a @formation.bio email address. If you receive outreach from someone
• claiming to work at Formation Bio through any other domain or channel, please
• disregard it and do not share any personal information.