Principal QA Specialist

Regeneron Pharmaceuticals, Inc; Munster; On-site; EUR 63,200 - 103,200; Full time

Job summary

Regeneron Pharmaceuticals, Inc in Raheen, Limerick is seeking a Principal QA Specialist to join the QA Compliance & Quality Systems team. This role focuses on Change Control governance, quality system oversight, and data integrity in a fast-paced biopharma environment.

You will review and approve Quality System documentation, support regulatory inspections, and collaborate across Manufacturing, Engineering, MSAT, and Regulatory Affairs to improve process effectiveness and inspection readiness.

Qualifications

• 7+ years of relevant work experience in pharmaceutical industry.
• BSc/BEng in scientific discipline or related field.
• Strong knowledge of cGMP and regulatory expectations.
• Experience with Change Control, Deviations, CAPAs and audits.
• Ability to collaborate cross-functionally and manage governance forums.

Responsibilities

• Provide SME oversight of Change Control governance and continuous improvement.
• Oversee Quality System processes, including Deviations, CAPAs, and audits.
• Review and approve Quality System documentation and records.
• Lead or support cross-functional governance meetings.
• Monitor quality metrics and drive process improvements.
• Support regulatory inspections and customer audits.

Skills

Change Control governance

Quality Systems

CAPA management

Audits

Regulatory inspections

Data integrity

Risk management

Quality documentation review

Cross-functional collaboration

Education

BSc/BEng in scientific discipline

Job description

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

• Serving as a Quality Systems Subject Matter Expert (SME) with primary responsibility for Change Control governance, oversight, and continuous improvement activities.
• Providing quality and compliance oversight of Quality System processes, including but not limited to: Change Control, Deviations, CAPA's, Audits, Customer Complaints and Risk Management.
• Ensuring Quality System records are managed in compliance with regulatory requirements, company procedures, and data integrity expectations.
• Reviewing and approving Quality System documentation, including Change Control records, Deviation investigations, CAPA plans and Risk assessments.
• Leading or supporting governance forums, review boards, and cross-functional meetings associated with Change Control and Quality System management.
• Monitoring, analysing, and communicating Quality System performance metrics and trends, finding opportunities to improve process effectiveness, efficiency, and compliance.
• Performing quality review of complex, high-impact, and cross-functional changes to ensure appropriate assessment of product quality, regulatory, validation, and operational impacts.
• Supporting regulatory inspections and customer audits, including preparation activities, presentation of Quality System processes, and response development for observations or commitments.
• Identifying compliance risks, process gaps, and systemic issues within Quality Systems and leads or supports development and implementation of sustainable corrective actions.
• Collaborating with Manufacturing, Quality Control, Engineering, MSAT, Supply Chain, Validation, Regulatory Affairs, and other site functions to ensure quality and compliance requirements are effectively integrated into business processes.
• Leading and participating in continuous improvement initiatives aimed at enhancing Quality System performance, inspection readiness, and operational excellence.
• Supporting the development, implementation, and maintenance of Quality System procedures, policies, and training programs.

The environment and physical rhythms of this role:

• Experience working with Quality Systems, including one or more of the following: Change Controls, Deviations, CAPA's, Audit Management and Risk Management
• Working knowledge of cGMP requirements and regulatory expectations.
• Strong organisational, communication, and stakeholder management skills, with the ability to effectively coordinate activities across multiple functional areas.
• Able to prioritise, re-prioritise as needed and adapt to change.
• Comfortable working in a fast-paced setting.

Let’s find out if we’re a fit:

• Requires BSc/BEng in scientific discipline or related field with 7+ years of relevant work experience in pharmaceutical or related industry.

Thrive today. Grow tomorrow.

#IRELIM #JOBSIEST #LI-Onsite

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! 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. If you have any questions, please speak with your recruiter.

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) €63,200.00 - €103,200.00