Principal QA Specialist

About the role

Regeneron, a biotechnology company developing medicines for serious diseases, is looking for a Principal QA Specialist to join its QA Compliance & Quality Systems team in Raheen, Limerick. The role acts as a Quality Systems Subject Matter Expert, responsible for Change Control governance, oversight and continuous improvement.

Key responsibilities

• Provide quality and compliance oversight of Quality System processes such as Change Control, deviations, CAPA, audits, customer complaints and risk management.
• Ensure Quality System records meet regulatory requirements, company procedures and data integrity expectations.
• Review and approve Quality System documentation, including Change Control records, deviation investigations, CAPA plans and risk assessments.
• Lead or support governance forums, review boards and cross-functional meetings on Change Control and Quality Systems.
• Monitor, analyse and communicate Quality System performance metrics and trends, and support regulatory inspections and customer audits.
• Identify compliance risks and process gaps and lead corrective actions.
• Collaborate with Manufacturing, Quality Control, Engineering, Validation, Regulatory Affairs and other site functions, and lead continuous improvement initiatives.
• Support the development, implementation and maintenance of Quality System procedures, policies and training programs.

Required profile

• BSc/BEng in a scientific discipline or related field.
• 7+ years of relevant work experience in the pharmaceutical or related industry.
• Experience with Quality Systems, including Change Controls, Deviations, CAPA, Audit Management and Risk Management.
• Strong organisational, communication and stakeholder management skills, able to prioritise and adapt to change in a fast-paced setting.

Required skills

• Working knowledge of cGMP requirements and regulatory expectations.

What we offer

• Salary range of EUR 63,200 to EUR 103,200 per year.
• Possible annual bonuses, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, insurance benefits, paid time off and family support benefits.