Director, QA Validation & Computer Systems Assurance

About the role

The Director of QA Validation is responsible for leading the QA Validation, Computer Systems Assurance (CSA), and Equipment Assurance functions for the Regeneron manufacturing site in Saratoga Springs, NY and Rensselaer, NY. Key responsibilities include:

• Own and maintain the site Validation Master Plan (VMP)
• Design and implement risk-based qualification and requalification programs
• Lead periodic review programs to maintain validated state for equipment, utilities, and automated systems
• Lead the CSA program in alignment with FDA's 2022 CSA guidance and GAMP 5 (2nd ed.)
• Own the site SDLC framework governing qualification and assurance of GxP-relevant software and computerized systems
• Oversee supplier/vendor assessments for software used in GxP contexts
• Ensure data integrity by design across automated and integrated systems
• Partner with IT, automation, and manufacturing engineering teams to integrate CSA requirements into system procurement, development, and change management processes
• Provide QA oversight for qualification of highly automated systems
• Review and approve GxP documents including validation protocols and reports, CSA plans and assessments, change controls, deviations/failure investigations, risk assessments, SOPs, and the VMP
• Provide QA validation and CSA oversight within the site change control system
• Present and defend validation and CSA programs during regulatory agency inspections
• Lead, develop, and retain a team of validation scientists, engineers, and CSA specialists
• Align validation and CSA strategies with site priorities and enterprise digital initiatives
• Communicate program status and risk posture to senior leadership

Responsibilities

Own and maintain the site Validation Master Plan (VMP), including scope for process, cleaning, sterilization, utilities, and equipment qualification across GMP manufacturing areas.

Design and implement risk-based qualification and requalification programs consistent with current FDA, EMA, and ICH guidance.

Ensure validation lifecycle documentation (URS, DQ, IQ, OQ, PQ, PV) meets regulatory expectations for commercial and clinical programs.

Lead periodic review programs to maintain validated state for equipment, utilities, and automated systems.

Lead the CSA program in alignment with FDA's 2022 CSA guidance and GAMP 5 (2nd ed.), shifting from prescriptive CSV toward risk-based, fit-for-purpose assurance activities.

Own the site SDLC framework governing qualification and assurance of GxP-relevant software and computerized systems, including MES (e.g., Syncade, PAS-X), DCS/SCADA, LIMS, EBR, ERP integrations, and data historians.

Establish critical thinking and scripted/unscripted testing strategies based on software category, intended use, and risk to product quality and patient safety.

Oversee supplier/vendor assessments for software used in GxP contexts, including software development lifecycle practices and audit readiness.

Ensure data integrity by design across automated and integrated systems, including audit trail configuration, access controls, and electronic records compliance (21 CFR Part 11/Annex 11).

Partner with IT, automation, and manufacturing engineering teams to integrate CSA requirements into system procurement, development, and change management processes.

Provide QA oversight for qualification of highly automated systems, including continuous manufacturing platforms, inline/online/at-line PAT instruments, and automated material handling systems.

Partner with automation and digital transformation teams to ensure GxP requirements are embedded in future-state manufacturing architecture, including digital twin environments.

Review and approve GxP documents including validation protocols and reports, CSA plans and assessments, change controls, deviations/failure investigations, risk assessments, SOPs, and the VMP.

Provide QA validation and CSA oversight within the site change control system, ensuring impact assessments and requalification/revalidation requirements are properly scoped.

Maintain periodic review programs for validated processes and qualified systems, including metrics-driven risk prioritization.

Present and defend validation and CSA programs during FDA, EMA, and other regulatory agency inspections; leads preparation of inspection-ready documentation and staff readiness.

Monitor evolving regulatory guidance (FDA, EMA, PIC/S, USP) relevant to validation, CSA, data integrity, and computerized systems.

Lead, develop, and retain a team of validation scientists, engineers, and CSA specialists across a complex, multi-system GMP environment.

Manage validation and CSA budgets, contractor resources, and schedules; sets performance objectives and manages hiring and separation activities.

Collaborate with Manufacturing, Engineering, Automation, IT, and Regulatory Affairs to align validation and CSA strategies with site priorities and enterprise digital initiatives; communicates program status and risk posture to senior leadership.

Support global quality alignment across Regeneron manufacturing facilities on validation and CSA standards and best practices.

Requirements

BS/BA required in Engineering, Computer Science, Life Sciences, or related field; advanced degree preferred.

12+ years of experience in pharmaceutical or biopharmaceutical manufacturing, including at least 7 years in validation, CSA, or quality assurance roles.

5+ years of people management experience in a GxP environment.

Direct experience leading computer systems assurance or CSV programs for commercial biologics or pharmaceutical manufacturing sites required.

Working knowledge of SDLC methodologies applied to GxP software (GAMP 5, 2nd ed.), FDA CSA guidance (2022), 21 CFR Part 11, EU Annex 11, and ICH Q9(R1)/Q10.

Experience with MES, DCS/SCADA, LIMS, and ERP/EBR systems in a GMP context required.

Experience representing validation and CSA programs in regulatory inspections (FDA PAI, BPAI, or EMA inspections) preferred.

Strong working knowledge of risk management principles and their application to validation and software assurance decisions.