Senior Manager Quality, Internal Audit

Location: Troy, New York, United States
Work model: Monday-Friday, 8am-4:30pm
Travel: 25-30% domestic & occasionally international

About the Role

Provide professional expertise, leadership, and oversight for the Regeneron Industrial Operations and Product Supply (IOPS) Quality Auditing function. This role contributes to a fast-growing, science-driven organization making a meaningful difference to patients worldwide by maintaining up-to-date expertise in global GxP regulations and internal policies, leading enterprise audit programs, and driving continuous improvement in auditing processes.

Responsibilities

• Maintain up-to-date expertise in global GxP regulations and standards (Chapter 21 of the Code of Federal Regulations, Eudralex Volume 4 and associated Annexes, ISO Standards, ICH, WHO, and IPEC Guidelines, etc.) and internal policies; track and communicate industry trends, agency expectations, and warning letters
• Lead enterprise audit programs (internal and external) across GMP, IT, and quality: set strategy, build schedules, plan, assign, and personally lead/participate in audits; ensure inspection readiness
• Manage cross-functional and supplier relationships (procurement, manufacturing, quality, external manufacturing, quality assurance, operations, audit clients) to meet audit schedules, quality deliverables, and organizational goals
• Provide leadership and subject-matter guidance to auditors; recruit, select, train, and assess external proxy auditors; coach, mentor, and develop internal GMP auditing staff; maintain robust training and qualification programs
• Ensure auditing processes meet regulatory and industry requirements; carry out adherence to procedures; document and assess deviations and changes per IOPS processes; uphold safety and operational standards
• Develop, maintain, and present metrics and targets (including RTO) to senior leadership to measure strategy execution and the health of quality auditing systems
• Drive continuous improvement by periodically reassessing auditing processes; translate ambiguity into actionable plans; proactively solve problems to prevent deviations and operational issues
• Accountable for team performance and outcomes of internal/external audit programs, including managing leaders where applicable; support inspections as needed

Requirements

• BS/BA in Life Sciences or equivalent combination of education and 8+ years of relevant experience
• Experience with quality systems and auditing
• Previous leadership/supervisory experience

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
• Family support benefits

Pay

Salary Range (annually): $126,300.00 - $206,100.00

Schedule

Monday-Friday, 8am-4:30pm