Job Description
Regeneron Manager GMP Compliance & Inspections
Drive continuous GMP compliance in Regeneron IOPS, promoting inspection readiness and regulatory compliance through proactive evaluation and education.
- Work with cross-functional teams to ensure GMP compliance and inspection readiness
- Lead proactive evaluation and education of site GMP compliance against current and emerging regulatory trends
- Support regulatory inspections and partner audits in creating, maintaining, and managing inspection content
- Evaluate outcomes of regulatory authority inspections/partner and other audits to identify near misses and lessons learned
- Establish and maintain a communication process mechanism to site management on the status of regulatory inspection readiness and CAPA commitments
- Evaluate and manage proposed commitments to regulatory authorities/audit bodies in response to inspection/audit findings
- Work collaboratively with commitment owners to ensure timely closure and effectiveness checks
- Generate, develop, and report metrics/trends for program adherence to requirements and effectiveness
- Support and lead teams implementing practices and improvements to make IOPS inspection-ready at all times
- Build and implement tools to improve IOPS inspection readiness; determine system improvements through effective project management
- Participate on internal committees/teams, as required
- Provide advice and direction to company departments on quality and regulatory issues
- Coordinating Regeneron information to support regulatory requests for paper inspections and/or observation responses
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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.
Regeneron is committed to providing a comprehensive benefits package, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.
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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.