Manager/Sr Manager GMP Compliance & Inspections

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 outstanding ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

Our medicines and pipeline are crafted to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases. Our mission is to use the power of science to bring new medicines to our patients

Summary : The Manager OR Sr Manager GMP Compliance & Inspections will work with cross-functional teams to drive activities that will ensure a state of continuous GMP compliance in Regeneron IOPS. This role will also promote and drive compliance by building inspection readiness processes across the organization. This individual will also 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 Manager OR Sr Manager GMP Compliance & Inspections a typical day may include:

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Working with department leaders and cross functional teams to educate, build and maintain an inspection readiness structure across the organization.

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Lead proactive evaluation and education of site GMP compliance against current and emerging regulatory trends.

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Supports regulatory inspections and partner audits in the creation, maintenance and management of inspection content, ensuring it is organized, current and readily accessible at all times.

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Respond to incoming enquiries during inspections and audits and ensure timely and accurate responses.

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Evaluate outcomes of regulatory authority inspections/partner and other audits to identify near misses, lessons learned and other best practices and works cross-functionally to ensure identified process or system improvement opportunities are sustainably implemented.

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Establish and maintain a communication process mechanism to site management on the status of regulatory inspection readiness and CAPA commitments.

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Evaluate and manage proposed commitments to regulatory authorities/audit bodies in response to inspection/audit findings.

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Work collaboratively with commitment owners to ensure that all commitment timelines are met via proactive CAPA tracking, and confirm their timely closure and ensure suitable effectiveness checks are in place.

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Utilise strong critical thinking skills to serve as a thought partner to the GMP Compliance and Inspections leadership with regard to complex problems.

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Generate, develop and report metrics / trends for program adherence to requirements and effectiveness.

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Support and lead teams implementing practices and improvements to make IOPS inspection-ready at all times.

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Build and implement tools to improve IOPS inspection readiness; determine system improvements through effective project management.

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Liaison with partners on audit/inspection and quality related matters to provide guidance and advice.

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Participates on internal committees/teams, as required.

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Provide advice and direction to company departments on quality and regulatory issues.

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Cross-site support of inspection readiness and inspection activities.

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Coordinate Regeneron information to support regulatory requests for paper inspections and/or observation responses.

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Additional duties may be assigned as required.

Education and Experience

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Manager: Requires a BA/BS degree in Life Sciences and 7+ years of relevant experience, preferably in the pharmaceutical or biotech industries or related field or equivalent combination of education and experience.

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Sr Manager: Requires a BA/BS degree in Life Sciences and 8+ years of relevant experience, preferably in the pharmaceutical or biotech industries or related field or equivalent combination of education and experience.

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 outstanding ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

Our medicines and pipeline are crafted to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases. Our mission is to use the power of science to bring new medicines to our patients

#IRELIM

#IREADV

#JOBSIEPR

#LI-Onsite

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and 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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.