Director, QA Validation & Computer Systems Assurance

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.

• Location:
  
  Saratoga Springs, NY and Rensselaer, NY

• Work model:
  Monday-Friday, 8am-4:30pm

• 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, E , 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…