Director GMP Compliance and Inspections

Regeneron Pharmaceuticals, Inc; Munster; On-site; EUR 102,000 - 200,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Director GMP Compliance & Inspections to join the Quality department at the IOPS Manufacturing site in Limerick. This leadership role will ensure regulatory readiness, drive continuous improvement, and coordinate inspections and audits to maintain the highest GMP standards.

The position is onsite in Limerick, with Monday–Friday work hours. The role requires a bachelor’s degree in Life Sciences and extensive experience in regulatory compliance,

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• Minimum of 12 years experience in a similar role.

Responsibilities

• Leading compliance assessments and inspection readiness initiatives across the site.
• Monitoring regulatory trends and translating them into actionable improvements.
• Developing tools, processes, metrics, and content repositories to support audit and inspection preparedness.
• Providing expert guidance on quality and regulatory matters to internal teams and external partners.
• Acting as a key liaison with regulatory agencies, customers, and partner quality organisations.
• Supporting regulatory inspections and internal audits, including coordinating responses and managing information requests.
• Benchmarking best practices and driving continuous improvement to maintain inspection readiness.

Education

Bachelor’s degree in Life Sciences

Job description

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Director GMP Compliance & Inspections to join our Quality department, supporting our IOPS Manufacturing site in Limerick. In this role, you will serve as a strategic compliance leader, ensuring regulatory readiness, driving continuous improvement, and coordinating inspection and audit activities to maintain the highest standards of GMP compliance.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

• Location: Limerick

• Work model: Onsite, Monday-Friday

Discover your role:

• Leading compliance assessments and inspection readiness initiatives across the site

• Monitoring regulatory trends and translating them into actionable improvements

• Developing tools, processes, metrics, and content repositories to support audit and inspection preparedness

• Providing expert guidance on quality and regulatory matters to internal teams and external partners

• Acting as a key liaison with regulatory agencies, customers, and partner quality organisations

• Supporting regulatory inspections and internal audits, including coordinating responses and managing information requests

• Benchmarking best practices and driving continuous improvement to maintain a state of inspection readiness at all times

• Partnering with compliance and quality teams to identify gaps, resolve issues, and strengthen compliance capabilities across operations

This role requires:

• Bachelor’s degree in Life Sciences or related field, or equivalent combination of education and experience, and a minimum of 12 years experience in a similar role

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, and 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. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

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

Salary Range (annually)

€101,500.00 - €200,400.00