QA Compliance Lead: Change Control & CAPA (Equity)

Regeneron Ireland; Limerick; Presencial; EUR 46.000 - 75.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

annual bonuses or other incentiveplans

equity awards

pension or retirement benefits

401(k) company match

health and wellness programs

fitness centers

insurance benefits (e.g. medical, dent

insurance benefits (e.g. medical, dent

paid time off

family support benefits

Descripción de la vacante

Regeneron Ireland seeks a QA Compliance Specialist to join the QA Compliance & Quality Systems team in Raheen, Limerick. You will support Change Control records administration, provide quality oversight across the change lifecycle, and review key quality documentation to ensure regulatory compliance.

You'll collaborate with Manufacturing, QA, Engineering, Validation, and Supply Chain to assess impacts and ensure timely execution of changes, CAPAs, and risk assessments, contributing to a robust

Formación

• 3–5+ years of relevant experience in the pharmaceutical/biotechnology industry.
• Experience with Quality Systems, Change Controls, Deviations, CAPA's, and risk management.
• Working knowledge of cGMP requirements and regulatory expectations.

Responsabilidades

• Supporting administration, review, and coordination of Change Control records to ensure regulatory compliance.
• Providing quality oversight of Change Control activities across the lifecycle.
• Reviewing and approving Quality System documentation (Change Controls, Deviation investigations, CAPA's, SOPs, Work Instructions).
• Collaborating with Manufacturing, QA, Engineering, Validation, Supply Chain, MSAT and others to assess impacts and implement changes.
• Ensuring Change Controls are categorized, documented, and tracked within timelines.
• Supporting quality system governance, monitoring open records, escalating risks, and driving corrective actions.
• Assisting in training on Change Control and Quality System processes.
• Participating in continuous improvement initiatives to enhance Quality System effectiveness.

Conocimientos

Quality Systems

Change Controls

Deviations

CAPA

Audit Management

Risk Management

Regulatory knowledge

Educación

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

Descripción del empleo

Regeneron Ireland seeks a QA Compliance Specialist to join the QA Compliance & Quality Systems team in Raheen, Limerick. You will support Change Control records administration, provide quality oversight across the change lifecycle, and review key quality documentation to ensure regulatory compliance.

You'll collaborate with Manufacturing, QA, Engineering, Validation, and Supply Chain to assess impacts and ensure timely execution of changes, CAPAs, and risk assessments, contributing to a robust