Senior Manager Quality, Internal Audit

Regeneron Pharmaceuticals, Inc (USA); United States; On-site; USD 126,000 - 206,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in Troy, New York is seeking a Senior Manager to lead the Quality Assurance internal auditing team.

You will provide expert leadership for GMP, IT, and quality audits and help set strategy for the Regeneron IOPS auditing function. The role involves building audit programs, coordinating cross-functional stakeholders, mentoring auditors, ensuring regulatory compliance, and presenting metrics to senior leadership.

Qualifications

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

Responsibilities

• Lead internal and external audit programs across GMP, IT, and quality.
• Set strategy, build schedules, plan audits, and ensure readiness.
• Manage cross-functional relationships to meet audit timelines.
• Coach, mentor, and develop GMP auditing staff.
• Present metrics to senior leadership on audit health.
• Drive continuous improvement of auditing processes.

Skills

Quality auditing

Leadership

GxP compliance

Auditing programs

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

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

Does this sound like you?

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 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
• family support benefits

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. 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.

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases.

Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

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

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