Director, QA Validation & Computer Systems Assurance

Build our future together:

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.

When & where:

• Location: Saratoga Springs NY and Rensselaer NY

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

Discover your role:

• 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 FDAs 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

This role requires:

• 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

#REGNQA

Does this sound like you Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race color religion or belief (or lack thereof) sex sexual orientation gender identity or expression gender reassignment marital or civil partnership status civil status pregnancy or parental status age disability nationality citizenship status ethnic or national origin membership of the Traveler community familial status genetic information military or veteran status or any other characteristic protected under applicable law. Where required we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process unless such accommodation would impose undue hardship.

Where necessary we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment specific role level and your skills and some countries collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include depending on country and role: annual bonuses or other incentive plans equity awards pension or retirement benefits 401(k) company match health and wellness programs fitness centers insurance benefits (e.g. medical dental vision life and disability) paid time off and family support benefits. For additional information about Regeneron benefits in the U.S. please visit For other locations additional information will be provided during the recruitment process. If you have any questions please speak with your recruiter.

Please be advised that at Regeneron we believe we do our best work when we are together. For that reason many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)