QA Compliance Specialist

At Regeneron, we use science and innovation to develop life changing medicines for people with serious diseases.

Regeneron is currently seeking a QA Compliance 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.

Location: Raheen, Limerick

What you'll do:

• Support the administration, review, and coordination of Change Control records to ensure compliance with company procedures and regulatory requirements.
• Provide quality oversight of Change Control activities throughout the change lifecycle, including initiation, impact assessment, implementation, effectiveness verification, and closure.
• Review and approve Quality System documentation, including change control records, deviation investigations, CAPA records, risk assessments, standard operating procedures, work instructions, and associated quality documentation.
• Collaborate with manufacturing, quality control, engineering, validation, supply chain, MSAT, and other functional areas to ensure appropriate assessment and implementation of proposed changes.
• Ensure change controls are appropriately categorised, documented, assessed for impact, and progressed in accordance with established timelines.
• Support quality system governance activities, including monitoring open records, escalating risks, and driving timely completion of actions.
• Assist in the generation, monitoring, and trending of Quality System metrics to support management review and continuous improvement initiatives.
• Participate in investigations related to change controls and support identification and implementation of corrective and preventive actions where required.
• Support the development and delivery of training on change control and quality system processes.
• Actively participate in continuous improvement initiatives to enhance quality system effectiveness, compliance, and efficiency.

Qualifications:

• Bachelor's degree in Science, Engineering, Pharmacy, Biotechnology, or a related discipline.
• 3-5+ years of relevant experience in the pharmaceutical, biotechnology, or other regulated industry.
• Relevant experience may be considered in lieu of educational requirements.
• Experience working with Quality Systems, including one or more of the following: change controls, deviations, CAPAs, audit management, and risk management.
• Working knowledge of cGMP requirements and regulatory expectations.
• Strong organisational, communication, and stakeholder management skills, with the ability to coordinate activities across multiple functional areas.
• Biologics manufacturing experience desirable.

Compensation:

• Salary Range (annually): €46,200.00 - €75,400.00

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 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, a 401(k) company match, health and wellness programs, fitness centers, insurance benefits (medical, dental, vision, life and disability), paid time off, and family support benefits.