Formation Bio

Formation Bio

Director/Senior Director, Data Governance

Boston, MA; New York, NY · Director

Sponsorship not specified$186k-$232kDetected 2 days ago
GCPMachine LearningSparkGMPResearchCommunicationCollaborationGxP

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odds of building a lasting career here

59Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70

Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.

Lottery odds assume a STEM candidate.

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About the role

  • About Formation Bio Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development.
  • The company is backed by investors across pharma and tech, including a16z, Sequoia, Sanofi, Thrive Capital, John Doerr, Spark Capital, SV Angel Growth, and others.
  • About the Position The Data Governance 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.

Responsibilities

  • 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
  • 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
  • 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
  • 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
  • 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

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
  • 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
  • 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

Skills

  • Our Vision for AI in Pharma
  • Our Current Drug Portfolio
  • Our Technology & Platform

Compensation

  • Individual compensation is determined by several factors, including role scope, geographic location, and skills & experience.
  • In addition to base salary, we offer equity, comprehensive benefits, and generous perks.
  • $185,500 - $232,000

Company info

  • You can read more at the following links: - Our Vision for AI in Pharma - Our Current Drug Portfolio - Our Technology & Platform 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.
  • We are an equal opportunity employer and welcome candidates from all backgrounds.

Equal opportunity

  • Formation Bio is committed to building a diverse and inclusive team. We are an equal opportunity employer and welcome candidates from all backgrounds. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, ancestry, sex (including pregnancy, childbirth, breastfeeding, and related medical conditions), gender identity or expression, sexual orientation, age, disability, genetic information, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law.
  • 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.
  • Formation Bio is committed to building a diverse and inclusive team.
  • All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, ancestry, sex (including pregnancy, childbirth, breastfeeding, and related medical conditions), gender identity or expression, sexual orientation, age, disability, genetic information, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law.
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