The Manager of GMP Compliance & Inspections will work with cross-functional teams to drive activities to prepare, execute and follow through on audits and inspection at Regenerons manufacturing site IOPS. This role will also engage with internal auditors, partner auditors and regulators and play a leading role in the preparation and execution of regulatory inspections, partner audits and internal audits, as well as follow up post audit/inspection on any items requiring response and action.

As the Manager GMP Compliance & Inspections, a typical day might include the following:

• Working with department leaders and cross functional teams to educate, build and maintain an inspection readiness structure across the organization
• Supporting regulatory inspections and partner audits in the creation, maintaining and managing inspection content, ensuring it is organized, current and readily accessible at all times
• Responding to incoming inquiries during inspections and audits and ensuring timely and accurate responses
• Evaluating outcomes of regulatory authority inspections/partner and other audits to identify near misses, lessons learned and other standard processes and working cross-functionally to ensure identified process or system improvement opportunities are sustainably implemented
• Establishing and maintaining a communication process mechanism to site management on the status of regulatory inspection readiness and CAPA commitments
• Evaluating and leading proposed commitments to regulatory authorities/audit bodies in response to inspection/audit findings
• Working collaboratively with commitment owners to ensure that all commitment timelines are met via proactive CAPA tracking, and confirming their timely closure and ensuring suitable effectiveness checks are in place
• Utilizing strong critical thinking skills to serve as a thought partner to the GMP Compliance and Inspections leadership with regard to complex problems
• Generating, developing and reporting metrics / trends for program adherence to requirements and effectiveness
• Supporting and leading teams implementing practices and improvements to make IOPS inspection-ready at all times
• Liaising with partners on audit/inspection and quality related matters to provide guidance and advice
• Participating on internal committees/teams, as required.
• Coordinating Regeneron information to support regulatory requests for paper inspections and/or observation responses
• Additional duties may be assigned as required

This role may be for you if you:

• Are knowledgeable in industry practices and regulations (cGMP, Annex I) and across multiple health authorities (e.g. FDA, EMA, MHRA, etc.)
• Excel in a quality driven organization
• Have an understanding of biologics manufacturing operations

To be considered for this role you must hold a Bachelor’s degree in Life Sciences and the following amount of related experience, preferably in the pharmaceutical or biotech industries or related field, for each level:

• Associate Manager – 6+ years
• Manager – 7+ years
• Sr Manager – 8+ years

May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.

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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$92,200.00 - $150,600.00