QA Compliance Specialist

Regeneron; Limerick; On-site; EUR 46,200 - 75,400; Full time

Job summary

Regeneron in Raheen, Limerick, is seeking a Quality Systems specialist to support Change Control administration, review, and lifecycle oversight. You will ensure compliance with cGMP and regulatory expectations while coordinating with Manufacturing, QA, Engineering, Validation, and Supply Chain to implement approved changes.

The role emphasizes governance, timely action on open records, CAPA investigations, and developing training on Change Control and Quality System processes.

Qualifications

• Bachelor's degree in Science, Engineering, Pharmacy, Biotechnology, or a related discipline.
• Requires 3-5+ years of experience in pharma/biotech or other regulated industries.
• Relevant experience may substitute for formal education.

Responsibilities

• Supporting administration, review, and coordination of Change Control records.
• Providing quality oversight of Change Control activities through lifecycle.
• Reviewing and approving Quality System documentation (Change Control, CAPA, Deviations, risk assessments, SOPs).
• Collaborating with Manufacturing, Quality Control, Engineering, Validation, Supply Chain and others.
• Ensuring Change Controls are categorized, assessed for impact, and progressed per timelines.
• Supporting governance activities, monitoring open records, escalating risks, driving actions.
• Assisting in generation, monitoring, and trending of Quality System metrics.
• Participating in investigations and CAPA actions; developing training on Change Control.

Skills

Change Control

Deviations

CAPA

Audit Management

Risk Management

Documentation

Education

Bachelor's degree in Science or Engineering or Pharmacy or Biotechnology

Job description

When & Where

• Location: Raheen, Limerick

What You’ll Do

• Supporting the administration, review, and coordination of Change Control records to ensure compliance with company procedures and regulatory requirements.
• Providing quality oversight of Change Control activities throughout the change lifecycle, including initiation, impact assessment, implementation, effectiveness verification, and closure.
• Reviewing and approving Quality System documentation, including: Change Control records, Deviation investigations, CAPA records, Risk assessments, Standard Operating Procedures and Work Instructions and associated quality documentation.
• Collaborating with Manufacturing, Quality Control, Engineering, Validation, Supply Chain, MSAT, and other functional areas to ensure appropriate assessment and implementation of proposed changes.
• Ensuring Change Controls are appropriately categorised, documented, assessed for impact, and progressed in accordance with established timelines.
• Supporting quality system governance activities, including monitoring open records, escalating risks, and driving timely completion of actions.
• Assisting in the generation, monitoring, and trending of Quality System metrics to support management review and continuous improvement initiatives.
• Participating in investigations related to Change Controls and supporting identification and implementation of corrective and preventive actions where required.
• Supporting the development and delivery of training on Change Control and Quality System processes.
• Actively participating in continuous improvement initiatives to enhance Quality System effectiveness, compliance, and efficiency.

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.
• Biologics manufacturing experience desirable.

Let’s Find Out If We’re a Fit

• Bachelor's degree in Science, Engineering, Pharmacy, Biotechnology, or a related discipline.
• Requires 3-5+ years of relevant experience in the pharmaceutical, biotechnology, or other regulated industry.
• Relevant experience may be considered in lieu of educational requirements.

Salary Range (annually)

€46,200 – €75,400

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.

We offer a comprehensive total rewards package, including 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.