Senior Manager, Data Governance & Data Integrity, Computer System Validation Program

The Senior Manager, Data Governance & Data Integrity (DG/DI) and CSV/CSA Program will own and advance two critical, interdependent quality programs that underpin enterprise regulatory compliance and operational excellence within the global Quality organization and Technical Operations. The DG/DI program has established a strong foundation and now requires focused maturation — building program depth through defined KPIs, metrics, and maturity assessments;

continuously strengthening alignment with evolving global regulatory requirements; and integrating emerging technology considerations such as AI/ML data integrity requirements into the QMS. The CSV/CSA program is an established enterprise function but is fragmented across the business, creating cost inefficiencies and inconsistency in execution; this role will drive harmonization of the CSV/CSA framework to achieve a unified, risk‑based approach across all sites and functions.

The ideal candidate possesses deep expertise in data integrity, data governance, and GxP computerized system validation, with a demonstrated ability to mature and harmonize programs across a complex, multi‑site enterprise. They bring strong command of evolving global regulatory expectations — including AI/ML validation frameworks, EU GMP Annex 11, and Computer Software Assurance — and can translate those requirements into practical program enhancements that keep the organization ahead of the compliance curve.

The ideal candidate will assess program maturity, define meaningful KPIs and metrics, and identify gaps and priorities that drive continuous improvement across both disciplines. In this role, you will serve as the enterprise subject matter expert and the central force for elevating DG/DI program maturity and unifying a fragmented CSV/CSA landscape — reducing cost and inefficiency while building long‑term organizational capability and regulatory resilience.

• Serve as the enterprise subject matter expert for data integrity, data lifecycle management, ALCOA+ principles, and GxP data governance frameworks (FDA, EMA, MHRA, WHO, PIC/S); define program strategy, KPIs, and maturity assessments to drive measurable and sustained DG/DI program enhancement.
• Lead the integration of Data Integrity by Design (DI by Design) principles into QMS processes, procedures, and system design; establish program maturity benchmarks and track enterprise‑wide progress against defined targets.
• Support site and function DI gap assessments and remediation strategy; identify compliance risks, drive visibility and resolution with DI Leads and site management, and provide expert technical guidance and direction.
• Design the enterprise DG/DI training model and co‑develop role‑based curricula in partnership with global and site training coordinators and DI Leads, building sustained data integrity capability across the organization.
• Lead the DG/DI Governance Program and Quality Plan; ensure DI Leads maintain progress against commitments, elevate issues to executive management, and present program status, risk landscape, and key metrics at Quality Management and Quality System review forums.
• Serve as the primary DG/DI subject matter expert for internal and external audits and regulatory inspections; prepare supporting documentation, respond to findings, and ensure remediation is tracked to closure.
• Own the DG/DI QMS SOPs and supporting procedures; ensure harmonization and alignment across the QMS hierarchy and consistent application of DI requirements enterprise wide.
• Monitor and translate emerging regulatory requirements (EU GMP Annex 11 revised, Annex 22, Chapter 4, AI/ML DI frameworks, FAIR data principles) into actionable QMS and program updates; cultivate strong partnerships with IT, CSV leads, DI Leads, BPOs, and system owners to secure alignment and ensure sustained adoption.

• Provide QA oversight and strategic direction for enterprise computerized system CSV/CSA programs; define validation strategy, GxP applicability determinations, and risk‑based…