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Formation Bio is a tech and AI-driven pharmaceutical company founded in 2016 (originally TrialSpark Inc.) that accelerates drug development and clinical trials through advanced technology platforms and processes. The company partners with pharma companies, research organizations, and biotechs to develop drug candidates past clinical proof of concept, addressing the industry bottleneck where AI-generated candidate drugs exceed the capacity of traditional clinical trial infrastructure. Formation Bio is backed by leading investors including a16z, Sequoia, Sanofi, Thrive Capital, and others.
The Associate Director/Director of Digital Quality is a critical member of the Quality Governance team, reporting directly to the Head of Quality with no intermediate management layer. This role owns data governance and AI oversight across Formation Bio's R&D organization, serving as Process Owner for R&D Data and Records Integrity and Business Owner for key quality technology systems (Veeva Quality Docs, DocuSign Part 11).
Key responsibilities include: maintaining the R&D data governance framework and inventory of R&D data (categories, stewards, source of truth, retention, access controls) with associated risk assessments; applying risk assessments and control strategies to computerized systems and AI tools; maintaining an inventory of AI applications across R&D with ongoing oversight to ensure continued control, compliance, and human accountability; advising R&D teams on data stewardship, data quality, and responsible AI adoption; owning strategy for large cross-functional data migration and digitization projects; establishing guardrails for AI use in QMS process execution; contributing to audit schedules and vendor qualification programs; overseeing and approving non-program-specific Quality Events, Investigations, and CAPAs; representing Quality Governance in regulatory inspections and third-party audits; and partnering cross-functionally to embed Quality by Design principles.
At the Director level, this role also sets R&D data governance and AI oversight strategy and represents Quality Governance during regulatory inspections. The position requires 10+ years of progressive GxP quality assurance, data integrity, or computerized systems compliance experience in pharmaceutical, biotech, or related regulated industries.
