# Associate Director/Director, Digital Quality

**Company**: Formation Bio
**Location**: Boston, MA
**Work arrangement**: hybrid
**Experience**: senior
**Job type**: full-time
**Salary**: $161,500 - $202,000
**Category**: IT
**Industry**: Healthcare

**Apply**: https://job-boards.greenhouse.io/formationbio/jobs/8120161?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_7f94a423-80e

## Description

Formation Bio is seeking an Associate Director/Director, Digital Quality to join their Quality Governance team. The successful candidate will serve as Process Owner for R&D Data and Records Integrity and as Business Owner for key quality technology systems.

Responsibilities:

- Serve as Process Owner for R&D Data and Records Integrity and Business Owner for Veeva Quality Docs and DocuSign Part 11

- 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

Requirements:

- 7+ years (Associate Director) or 10+ years (Director) of progressive GxP quality assurance, data integrity, or computerized systems compliance experience

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

- Strong working knowledge of data integrity principles and applicable GMP, GCP, and/or GLP regulations

- Demonstrated experience with computer system assurance/validation, including risk-based approaches

- Working knowledge of AI/ML risk concepts, including model validation, bias, explainability, and drift monitoring

- 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

Total Compensation Range: $161,500 - $202,000

## Skills

### Required
- GxP quality assurance
- data integrity
- computerized systems compliance
- data governance
- AI/ML risk concepts
- computer system assurance/validation
- risk-based approaches

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Source: [Apply at job-boards.greenhouse.io](https://job-boards.greenhouse.io/formationbio/jobs/8120161?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)