Sr Compliance Specialist-Manufacturing

Regeneron Pharmaceuticals, Inc; Munster; On-site; EUR 46,000 - 88,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in Ireland seeks a Sr Compliance Specialist to join the Manufacturing team in Raheen, Limerick. You will coordinate quality events, review information with Manufacturing Managers, and drive CAPA actions to prevent recurrence.

Responsibilities include risk assessments, technical write-ups, and supporting audits while ensuring cGMP compliance and proper documentation across batch records and SOPs.

Qualifications

• Requires Bachelor's degree in science or related field with experience in GMP/quality systems.
• Experience with deviations, CAPA, change control and documentation.
• Regulatory compliance experience in a manufacturing setting.

Responsibilities

• Coordinate and document manufacturing quality events including deviations, change controls, and CAPA.
• Review event information with Manufacturing Managers and assess impact on SISPQ.
• Perform risk assessments and initiate corrective actions to prevent recurrence.
• Coordinate internal investigations and prepare technical write-ups for reviews.
• Participate in leadership updates on quality event status and audits.

Skills

Quality compliance

Deviations management

Change control

Regulatory audits

Technical writing

Education

Science/Engineering degree

Job description

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

• Coordination and documentation of manufacturing quality events including Deviations, Change Control’s, Corrective and Preventative Actions
• Working closely with Manufacturing Managers to review and evaluate quality event information
• Assess event for impact to SISPQ, conduct risk assessments and initiate appropriate corrective actions to prevent reoccurrence
• Technical write up and coordination of internal reviews of investigational reports
• Participate in management meetings to update leadership on current status of quality events
• Reviews, edits, and revises controlled documents (batch records, logbooks, SOPs, etc.) in accordance with cGMP standards to ensure compliance with written procedures
• Tracks and monitors manufacturings open compliance records
• Participates in regulatory and customer audits
• Utilise problem solving methodologies such as fishbone, 5 Whys etc. to establish root cause of deviations

The environment and physical rhythms of this role:

• Demonstrated skills in problem solving in a cross functional setting, with the ability to keep the team aligned to achieve meeting objectives
• Ability to work to tight timelines and knows when to elevate actions appropriately for resolution in a timely manner
• Prior technical writing experience within a manufacturing environment preferred
• Must have the ability to work in a fast paced environment, with the ability to manage multiple events for on-time closure
• Must be a highly proactive, detail-oriented individual who has the ability to adapt to change quickly
• Strong written and verbal communication skills are required

Let’s find out if we’re a fit:

• Bachelor's degree in Science, Engineering, Pharmacy, Biotechnology, or a related discipline
• Specialist: 2+ years of relevant work experience
• Sr Specialist: 5+ years of relevant work experience
• Relevant experience may be considered in lieu of educational requirements

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. 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)

€46,200.00 - €88,400.00