Associate Director/Director, Digital Quality
Leads R&D data governance, computerized-system compliance, and AI oversight within Quality Governance. The role requires substantial GxP experience, data integrity and validation expertise, R&D governance experience, and the ability to lead cross-functional migration and inspection-readiness activities.
About the job
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 data inventories, stewardship and ownership models, sources of truth, retention requirements, access controls, and risk assessments.
- Apply risk assessments and control strategies to computerized systems and AI tools, including changes in context of use and functionality.
- Maintain the R&D AI application inventory and provide ongoing oversight, including periodic model reviews, human accountability, and continued compliance.
- Advise R&D teams on data stewardship, data quality, and responsible AI adoption.
- Lead cross-functional data migration, digitization, asset onboarding, and system-change initiatives.
- Establish guardrails for AI use in QMS processes such as investigation drafting, CAPA analysis, and audit preparation.
- Support the QA master audit schedule and vendor qualification program, including assessment of vendors' AI and automated systems in GxP-impacting work.
- Oversee, review, and approve non-program-specific Quality Events, Investigations, and CAPAs.
- Represent Quality Governance in regulatory inspections and third-party audits and support inspection readiness.
- Partner with R&D, IT, and Operational Excellence to embed Quality by Design into data, AI, and systems governance.
Requirements
- 7+ years of progressive GxP quality assurance, data integrity, or computerized systems compliance experience for Associate Director level; 10+ years for Director level.
- Bachelor's degree in a scientific, engineering, information systems, or related discipline.
- Strong knowledge of data integrity principles, including ALCOA+, and applicable GMP, GCP, and/or GLP regulations.
- Experience with computer system assurance and validation using risk-based approaches.
- Working knowledge of AI/ML risk concepts, including model validation, bias, explainability, and drift monitoring.
- Experience building or maintaining R&D data governance artifacts and overseeing AI applications used in R&D processes.
- Experience as a Process Owner or System/Business Owner, including SOP governance, KPI monitoring, and change control management.
- Experience contributing to cross-functional data migration, asset onboarding, or system-change projects.
- Strong cross-functional communication and collaboration skills, including experience representing Quality Assurance in inspections or regulatory interactions.
- Ability to work independently and exercise sound judgment.
Compensation and Benefits
- Total compensation range: $161,500–$202,000 USD.
- Compensation varies based on role scope, geographic location, skills, and experience.
- Equity, comprehensive benefits, and generous perks are included.
Skills
Gxp, Quality Assurance, Data Integrity, Alcoa+, Gmp, GCP, Glp, Computer System Assurance, Computerized System Validation, Ai/Ml Risk Assessment, Model Validation, Data Governance, Veeva Quality Docs, Docusign Part 11, Capa
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