Principal QA Specialist

BioSpace; Ireland (WV); Sur place; USD 71 000 - 116 000; Plein temps

Résumé du poste

Regeneron seeks a Principal QA Specialist to join the QA Compliance & Quality Systems team in Ireland. Location: Raheen, Limerick, onsite.

You will oversee Change Control governance, CAPA, deviations, audits, and risk management, ensuring data integrity and regulatory compliance across Quality System records and processes. With 7+ years in pharma, you will lead cross‑functional governance forums, drive continuous improvement, support regulatory inspections, and collaborate with Manufacturing,

Qualifications

• BSc/BEng in scientific discipline or related field.
• 7+ years of relevant work experience in pharmaceutical or related industry.
• Experience with Quality Systems, Change Controls, Deviations, CAPA, Audit Management, and Risk Management.

Responsabilités

• Serving as Quality Systems SME with primary responsibility for Change Control governance and continuous improvement.
• Providing quality and compliance oversight of Quality System processes including Change Control, Deviations, CAPA's, Audits and Risk Management.
• Ensuring Quality System records are managed in compliance with regulatory requirements and data integrity expectations.
• Reviewing and approving Quality System documentation including Change Control records, deviations and CAPA plans.
• Leading governance forums and cross‑functional meetings for Change Control and Quality System management.
• Monitoring Quality System performance metrics and trends to improve process effectiveness and compliance.
• Performing quality review of complex changes to assess product quality, regulatory, validation, and operational impacts.
• Supporting regulatory inspections and customer audits, including preparation and response development for observations.
• Identifying compliance risks and leading corrective actions and improvements.
• Collaborating with Manufacturing, QA, Engineering, Reg Affairs and other site functions to integrate quality and compliance into business processes.
• Leading continuous improvement initiatives to enhance Quality System performance and inspection readiness.
• Supporting development and maintenance of Quality System procedures, policies, and training.

Formation

BSc/BEng in scientific discipline or related field

Description du poste

Build Our Future Together 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.

Where

Location: Raheen, Limerick

What Youll 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.

Lets Find Out If Were 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 #REGNQA

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 onsite.

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.

Salary Range (annually)

63,200.00 - 103,200.00