QA Compliance & Quality Systems Specialist

Regeneron Pharmaceuticals, Inc; Munster; On-site; EUR 46,200 - 75,400; Full time

Job summary

Regeneron Pharmaceuticals, Inc is seeking a QA Compliance Specialist to join the QA Compliance & Quality Systems team in Raheen, Limerick. You will support Change Control activities, review quality systems documentation, and collaborate across functions to ensure compliance with regulatory expectations.

The role requires 3–5+ years in a regulated industry, a science/engineering degree, and strong knowledge of cGMP.

Qualifications

• Bachelor's degree in Science, Engineering, Pharmacy, Biotechnology, or a related discipline.
• 3–5+ years of relevant experience in pharmaceutical, biotechnology, or a regulated industry.
• Experience with Quality Systems, including Change Controls, Deviations, CAPA, Audit Management and Risk Management.
• Working knowledge of cGMP requirements and regulatory expectations.

Responsibilities

• Support administration, review, and coordination of Change Control records to ensure regulatory compliance.
• Provide quality oversight of Change Control activities across the lifecycle.
• Review and approve Quality System documentation (Change Controls, Deviations, CAPA, SOPs).
• Collaborate with Manufacturing, QC, Engineering, Validation, Supply Chain, MSAT, and other functions to implement changes.
• Ensure Change Controls are categorized, assessed for impact, and progressed on time.
• Support governance activities, monitor open records, escalate risks, and drive timely actions.
• Assist in generation and trending of Quality System metrics for management review.
• Participate in investigations related to Change Controls and CAPA implementation.
• Support training development on Change Control and Quality System processes.
• Contribute to continuous improvement to enhance Quality System effectiveness.

Skills

Quality Systems

Change Control

Deviations

CAPA

Audit Management

Risk Management

Education

Bachelor's degree in Science, Engineering, Pharmacy, Biotechnology, or related discipline

Job description

Regeneron Pharmaceuticals, Inc is seeking a QA Compliance Specialist to join the QA Compliance & Quality Systems team in Raheen, Limerick. You will support Change Control activities, review quality systems documentation, and collaborate across functions to ensure compliance with regulatory expectations.

The role requires 3–5+ years in a regulated industry, a science/engineering degree, and strong knowledge of cGMP.