Compliance Specialist External Manufacturing

Regeneron Pharmaceuticals, Inc; Munster; On-site; EUR 37,000 - 75,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc in Raheen, Limerick is seeking a Compliance Specialist External Manufacturing to join the Drug Product Manufacturing team. You will lead CAPAs and change controls, review procedures, and monitor cGMP compliance to maintain product integrity.

This on-site role requires 0-2 years for Associate Specialist or 2+ years for Specialist in cGMP operations, with travel up to 25% and potential supervisory responsibilities as needed.

Qualifications

• 0-2 years of related experience in cGMP manufacturing operations (clinical and/or commercial drug products) for Associate Specialist.
• 2+ years of related experience in cGMP manufacturing operations (clinical and/or commercial drug products) for Specialist.
• May consider equivalent combination of education and experience.

Responsibilities

• Leading and managing CAPAs and change controls.
• Reviewing and maintaining procedures, polices and other instructional documents with a focus on continuous improvement.
• Responsible for generating and tracking performance metrics.
• Maintaining knowledge of current good manufacturing practices cGMPs.
• Responsible for periodic reviews of Drug Product Manufacturing documentation and records to assess for compliance with established quality standards, policies and procedures.
• Travelling to contract manufacturers or business partners, as required (25% or less).
• Maintaining required training status on Regeneron specific work instructions and SOP’s.
• Assisting in maintenance of product integrity and company reputation by assisting in the monitoring of cGMP compliance at drug product contract manufacturers.
• Continuous Process Improvement Implementation.
• May require supervisory responsibilities.

Skills

CAPA management

Documentation control

Quality systems

Change control

Job description

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking a Compliance Specialist External Manufacturing to join our Drug Product Manufacturing team.

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

When & where:

• Location: Raheen, Limerick

What you’ll do:

• Leading and managing CAPAs and change controls
• Reviewing and maintaining procedures, polices and other instructional documents with a focus on continuous improvement
• Responsible for generating and tracking performance metrics
• Maintaining knowledge of current good manufacturing practices cGMPs
• Responsible for periodic reviews of Drug Product Manufacturing documentation and records to assess for compliance with established quality standards, policies and procedures
• Travelling to contract manufacturers or business partners, as required (25% or less)
• Maintaining required training status on Regeneron specific work instructions and SOP’s
• Assisting in maintenance of product integrity and company reputation by assisting in the monitoring of cGMP compliance at drug product contract manufacturers
• Continuous Process Improvement Implementation
• May require supervisory responsibilities

The environment and physical rhythms of this role:

• Able to prioritise, re-prioritise as needed and adapt to change
• Comfortable working in a fast-paced setting
• Ability to work independently or as part of a team
• Meets commitments on scope and on time

Let’s find out if we’re a fit:

• Associate Specialist: 0-2 years of related experience in cGMP manufacturing operations (clinical and/or commercial drug products)
• Specialist: 2+ years of related experience in cGMP manufacturing operations (clinical and/or commercial drug products)
• May consider equivalent combination of education and experience. Level will be determined based on qualification and experience relevant to the role

Thrive today. Grow tomorrow.

#IRELIM #JOBSIEST #LI-Onsite

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.

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)

€37,000.00 - €75,400.00