Associate Director/Director, Digital Quality

About Formation Bio Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more candidate drugs than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines to patients. 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. 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. 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. 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 About You 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 Total Compensation Range: $161,500 - $202,000 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. 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. 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. #J-18808-Ljbffr Socket.dev