Senior Manager Quality, Internal Audit

About the role

Regeneron is seeking a Senior Manager to join the Quality Assurance internal auditing team. The role provides professional expertise, leadership, oversight, and strategic planning for the Regeneron Industrial Operations and Product Supply (IOPS) Quality Auditing function. Quality (GMP) Auditing manages internal audit programs and performs internal audits for Regeneron IOPS, focusing on GMP, IT, and Quality audits that may impact GMP operations and/or products.

Responsibilities

• Maintain up‑to‑date expertise in global GxP regulations and standards (Chapter 21 of the CFR, Eudralex Volume 4 and annexes, ISO standards, ICH, WHO, 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; adhere 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.
• 8+ years of relevant experience.
• Experience with quality systems and auditing.
• Previous leadership/supervisory experience.

Schedule

Location: Troy, New York, United States

Work model: Monday‑Friday, 8 am‑4:30 pm

Travel: 25‑30 % domestic & occasionally international

Pay

Salary range (annually): $126,300 – $206,100

Benefits

• Competitive and comprehensive total rewards package.
• Annual bonuses or other incentive plans.
• Equity awards.
• Pension or retirement benefits, including 401(k) company match.
• Health and wellness programs and fitness centers.
• Insurance benefits (medical, dental, vision, life, disability).
• Paid time off.
• Family support benefits.
• Additional benefits information provided during the recruitment process.