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About the Role

The Digital Quality Associate Director/Director is a critical member of the Quality Governance team, focusing on data governance and AI oversight within Formation Bio's R&D organization. This role serves as Process Owner for R&D Data and Records Integrity and Business Owner for key quality technology systems, owning the inventory of R&D data and AI applications, along with their risk assessments. The role builds and maintains the data governance framework, performs AI risk assessments, and drives data migration and digitization initiatives to ensure compliance.

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 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
Serve as a key R&D partner on data governance matters, advising R&D teams on data stewardship, data quality, and responsible AI adoption
Own and drive strategy for large cross-functional data migration and digitization projects
Establish guardrails for the use of AI in QMS process execution
Contribute to and support the QA master audit schedule and vendor qualification program
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
Partner cross-functionally with R&D, IT, and Operational Excellence to embed Quality by Design principles into data, AI, and systems governance

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
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
Working knowledge of AI/ML risk concepts sufficient to design and approve AI risk assessments and mitigation strategies
Demonstrated experience building or maintaining data governance artifacts within an R&D setting
Demonstrated experience serving as a Process Owner or System/Business Owner
Experience leading or contributing substantively to cross-functional data migration, asset onboarding, or system change projects
Strong cross-functional communication and collaboration skills
Demonstrated ability to operate with a high degree of independence, exercising sound judgment

Skills

Data governance
AI oversight
R&D Data and Records Integrity
Veeva Quality Docs
DocuSign Part 11
Risk assessments
Data migration
Digitization initiatives
Computer system validation
AI/ML risk concepts
Data stewardship
Data quality
Responsible AI adoption
QMS process execution
Audit schedule
Vendor qualification
Quality Events
Investigations
CAPAs
Regulatory inspections
Third-party audits
Quality by Design

Location

New York City metro area
Boston metro area
Research Triangle (NC)
San Francisco Bay Area

Work Type

Hybrid

Experience Level

Associate Director
Director

Education Level

Bachelor's degree in a scientific, engineering, information systems, or related discipline

Salary/Compensations

$161,500 - $202,000

Benefits

Equity
Comprehensive benefits
Generous perks

About the Company

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.
Formation Bio has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials.
The company partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond.
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.

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.