Senior QA Systems Lead: Change Control & Compliance

BioSpace; Ireland (WV); On-site; USD 71,000 - 116,000; Full time

Job summary

Regeneron seeks a Principal QA Specialist to join the QA Compliance & Quality Systems team in Ireland. Location: Raheen, Limerick, onsite.

You will oversee Change Control governance, CAPA, deviations, audits, and risk management, ensuring data integrity and regulatory compliance across Quality System records and processes. With 7+ years in pharma, you will lead cross‑functional governance forums, drive continuous improvement, support regulatory inspections, and collaborate with Manufacturing,

Qualifications

• BSc/BEng in scientific discipline or related field.
• 7+ years of relevant work experience in pharmaceutical or related industry.
• Experience with Quality Systems, Change Controls, Deviations, CAPA, Audit Management, and Risk Management.

Responsibilities

• Serving as Quality Systems SME with primary responsibility for Change Control governance and continuous improvement.
• Providing quality and compliance oversight of Quality System processes including Change Control, Deviations, CAPA's, Audits and Risk Management.
• Ensuring Quality System records are managed in compliance with regulatory requirements and data integrity expectations.
• Reviewing and approving Quality System documentation including Change Control records, deviations and CAPA plans.
• Leading governance forums and cross‑functional meetings for Change Control and Quality System management.
• Monitoring Quality System performance metrics and trends to improve process effectiveness and compliance.
• Performing quality review of complex changes to assess product quality, regulatory, validation, and operational impacts.
• Supporting regulatory inspections and customer audits, including preparation and response development for observations.
• Identifying compliance risks and leading corrective actions and improvements.
• Collaborating with Manufacturing, QA, Engineering, Reg Affairs and other site functions to integrate quality and compliance into business processes.
• Leading continuous improvement initiatives to enhance Quality System performance and inspection readiness.
• Supporting development and maintenance of Quality System procedures, policies, and training.

Education

BSc/BEng in scientific discipline or related field

Job description

Regeneron seeks a Principal QA Specialist to join the QA Compliance & Quality Systems team in Ireland. Location: Raheen, Limerick, onsite.

You will oversee Change Control governance, CAPA, deviations, audits, and risk management, ensuring data integrity and regulatory compliance across Quality System records and processes. With 7+ years in pharma, you will lead cross‑functional governance forums, drive continuous improvement, support regulatory inspections, and collaborate with Manufacturing,