QC External Lab Coordinator

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking a QC External Laboratory Coordinator to join our Quality Control (QC) Support team. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Location & Travel

Location: Raheen, Limerick, Ireland.

Flexibility & Travel: Occasional travel may be required to support external laboratory partnerships and audits.

Other Requirements: Ability to work cross-functionally in a highly regulated Good Manufacturing Practice (GMP) environment.

Responsibilities

• Coordinate sample management and method transfer activities with external laboratories supporting manufacturing and quality control operations.
• Serve as a technical subject matter expert for analytical and microbiological method transfers, ensuring successful execution and compliance.
• Partner with Quality Assurance, Manufacturing, and external laboratories to resolve quality issues, investigations, and technical challenges.
• Review and approve method transfer documentation, quality records, and laboratory reports to support regulatory compliance.
• Drive continuous improvement initiatives while maintaining quality systems, including change controls, corrective and preventive actions, and Standard Operating Procedures (SOPs).

Work Environment

This role is primarily office and laboratory-based within a Good Manufacturing Practice (GMP) regulated environment.

May involve entering manufacturing, warehouse, or laboratory areas requiring appropriate gowning and personal protective equipment.

Requires routine use of computer systems and the ability to review technical documentation and laboratory data.

Requirements

• Bachelor's degree in Biology, Chemistry, Microbiology, or a related scientific discipline, or equivalent relevant experience.
• Experience in quality control, analytical testing, microbiology, or external laboratory management within a regulated industry.
• Knowledge of Good Manufacturing Practice (GMP) requirements and quality systems.
• Experience with method transfers, investigations, change controls, or contract laboratory oversight is preferred.