QA Compliance Lead: Change Control & Quality Systems

Regeneron; Limerick; On-site; EUR 63,200 - 103,200; Full time

Job summary

Regeneron is seeking a Principal QA Specialist to join the QA Compliance & Quality Systems team in Raheen, Limerick. You will lead Change Control governance, oversee Quality System processes and partner with multi‑functional groups to ensure compliance and data integrity.

Qualifications include a science degree and 7+ years in pharma QA. The role focuses on regulatory readiness, continuous improvement and inspection support at a busy biopharma site.

Qualifications

• 7+ years in pharmaceutical QA or related field.
• BSc/BEng in a scientific discipline.
• Experience with cGMP and regulatory expectations.

Responsibilities

• Serve as SME for Quality Systems with Change Control governance.
• Oversee changes, deviations, CAPA, audits, and risk management.
• Review and approve QA documentation and risk assessments.
• Lead or support governance forums and cross‑functional meetings.
• Monitor metrics and drive continuous improvement in QA systems.
• Support regulatory inspections and customer audits.
• Collaborate with Manufacturing, MSAT, Regulatory Affairs and other sites.

Skills

Quality Systems governance

Change Control

Regulatory compliance

Stakeholder management

Cross-functional collaboration

Education

BSc/BEng in a scientific discipline

Job description

Regeneron is seeking a Principal QA Specialist to join the QA Compliance & Quality Systems team in Raheen, Limerick. You will lead Change Control governance, oversee Quality System processes and partner with multi‑functional groups to ensure compliance and data integrity.

Qualifications include a science degree and 7+ years in pharma QA. The role focuses on regulatory readiness, continuous improvement and inspection support at a busy biopharma site.