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About the Role
Regeneron is seeking a Senior Manager to join their Quality Assurance internal auditing team. This role provides expertise, leadership, and oversight for the Regeneron Industrial Operations and Product Supply (IOPS) Quality Auditing function, focusing on GMP, IT, and Quality audits.
Responsibilities
- Maintain up-to-date expertise in global GxP regulations and standards 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 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 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.
Location
- Troy, New York, United States
Work Type
- Onsite
- Monday-Friday, 8am-4:30pm
Experience Level
- Senior Manager
Education Level
- BS/BA in Life Sciences
Salary/Compensations
- $126,300.00 - $206,100.00
Benefits
- 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
About the Company
- Regeneron uses science and innovation to develop life-changing medicines for people with serious diseases.
- We are committed to building a workplace with an inclusive culture.
- We believe we do our best work when we are together.
Equal Opportunity
- 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.