At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Director of QA Validation to lead the QA Validation, Computer Systems Assurance (CSA), and Equipment Assurance functions for the Regeneron manufacturing site located in Saratoga Springs, NY. The director is responsible for qualification and validation strategy across a highly automated, digitally integrated biopharmaceutical facility, including process equipment, utilities, manufacturing execution systems (MES), laboratory information management systems (LIMS), distributed control systems (DCS), and enterprise platforms. The role applies risk-based methodologies aligned with FDA CSA guidance, GAMP 5 (2nd ed.), ICH Q9(R1)/Q10, and SDLC frameworks to maintain validated state across commercial and clinical manufacturing, and represents and defends the validation and CSA programs during FDA, EMA, and other regulatory inspections.
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/atline 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 defends 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
Develop and 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
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
