Senior Manufacturing Quality & Compliance Lead

Regeneron; Limerick; On-site; EUR 85,000 - 105,000; Full time

Job summary

Regeneron is seeking a Sr Compliance Specialist to join our Manufacturing team in Raheen, Limerick. You will coordinate and document manufacturing quality events, review information with Manufacturing Managers, assess impact to regulatory and product quality, and drive corrective actions to prevent recurrence.

The role emphasizes problem solving, technical writing, and adherence to cGMP standards. You will contribute to internal investigations, audits, and the ongoing improvement of controlled

Qualifications

• Bachelor's degree in Science, Engineering, Pharmacy, Biotechnology, or a related discipline.
• Specialist: 2+ years of relevant work experience; Sr Specialist: 5+ years of relevant work experience.
• Relevant experience may be considered in lieu of educational requirements.

Responsibilities

• Coordinate and document manufacturing quality events including deviations, change controls, CAPAs.
• Review and evaluate quality event information with Manufacturing Managers.
• Assess events for SISPQ impact and perform risk assessments.
• Technical write up and coordination of internal reviews of investigational reports.
• Participate in management meetings to update leadership on current status of quality events.
• Review, edit, and revise controlled documents (batch records, SOPs) per cGMP.
• Track and monitor manufacturing open compliance records.
• Participate in regulatory and customer audits.
• Apply root-cause analysis tools (fishbone, 5 Whys) to deviations.

Skills

Quality events coordination

Regulatory awareness

Problem solving

Technical writing

Education

Bachelor's degree in Science/Engineering/Pharmacy/Biotechnology

Tools

cGMP knowledge

Job description

Regeneron is seeking a Sr Compliance Specialist to join our Manufacturing team in Raheen, Limerick. You will coordinate and document manufacturing quality events, review information with Manufacturing Managers, assess impact to regulatory and product quality, and drive corrective actions to prevent recurrence.

The role emphasizes problem solving, technical writing, and adherence to cGMP standards. You will contribute to internal investigations, audits, and the ongoing improvement of controlled