Quality Systems Lead: Change Control & Compliance

Regeneron Pharmaceuticals, Inc; Munster; On-site; EUR 63,200 - 103,200; Full time

Job summary

Regeneron Pharmaceuticals, Inc in Raheen, Limerick is seeking a Principal QA Specialist to join the QA Compliance & Quality Systems team. This role focuses on Change Control governance, quality system oversight, and data integrity in a fast-paced biopharma environment.

You will review and approve Quality System documentation, support regulatory inspections, and collaborate across Manufacturing, Engineering, MSAT, and Regulatory Affairs to improve process effectiveness and inspection readiness.

Qualifications

• 7+ years of relevant work experience in pharmaceutical industry.
• BSc/BEng in scientific discipline or related field.
• Strong knowledge of cGMP and regulatory expectations.
• Experience with Change Control, Deviations, CAPAs and audits.
• Ability to collaborate cross-functionally and manage governance forums.

Responsibilities

• Provide SME oversight of Change Control governance and continuous improvement.
• Oversee Quality System processes, including Deviations, CAPAs, and audits.
• Review and approve Quality System documentation and records.
• Lead or support cross-functional governance meetings.
• Monitor quality metrics and drive process improvements.
• Support regulatory inspections and customer audits.

Skills

Change Control governance

Quality Systems

CAPA management

Audits

Regulatory inspections

Data integrity

Risk management

Quality documentation review

Cross-functional collaboration

Education

BSc/BEng in scientific discipline

Job description

Regeneron Pharmaceuticals, Inc in Raheen, Limerick is seeking a Principal QA Specialist to join the QA Compliance & Quality Systems team. This role focuses on Change Control governance, quality system oversight, and data integrity in a fast-paced biopharma environment.

You will review and approve Quality System documentation, support regulatory inspections, and collaborate across Manufacturing, Engineering, MSAT, and Regulatory Affairs to improve process effectiveness and inspection readiness.