Senior Manager Quality Assurance, Internal Auditing

Regulatory Toolkit; City of Troy (NY); On-site; USD 126,000 - 206,000; Full time

Job summary

Regeneron is seeking a Senior Manager to lead its Quality Assurance internal auditing function within the IOps Quality Auditing program. This role focuses on GMP, IT, and quality audits, overseeing strategy, scheduling, and execution to ensure inspection readiness and compliance across global operations.

The candidate will mentor auditors, manage cross-functional relationships, and drive continuous improvement of auditing processes while maintaining regulatory alignment and robust training

Qualifications

• 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

Responsibilities

• Lead enterprise audit programs (internal and external) across GMP, IT, and quality; set strategy, build schedules, plan, assign, and participate in audits; ensure inspection readiness
• Manage cross-functional and supplier relationships to meet audit schedules, quality deliverables, and organizational goals
• Provide leadership and guidance to auditors; recruit, select, train, and assess external proxy auditors; coach and develop internal GMP auditing staff; maintain training 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 to senior leadership to measure strategy execution and the health of quality auditing systems
• Drive continuous improvement by reassessing auditing processes; translate ambiguity into actionable plans; solve problems to prevent deviations

Skills

Quality systems

Auditing

Leadership

Education

BS/BA in Life Sciences

Job description

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 Senior Manager to join our Quality Assurance internal auditing team. They are responsible for providing professional expertise, leadership, oversight and assisting with strategic planning for the Regeneron Industrial Operations and Product Supply (IOPS) Quality Auditing function. Quality (GMP) Auditing is responsible for managing the internal audit programs and performing internal audits for Regeneron IOPS, with primary emphasis on GMP, IT and Quality audits that may impact GMP operations and/or products. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

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

Discover your role:

• 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, and 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

This role requires:

• 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

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 experience. In 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 other locations, additional information will be provided during the recruitment process.

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 on‑site. Please speak with your recruiter and hiring manager for more information about on‑site 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)

$126,300.00 - $206,100.00