QC Lab Manager, GMP Leader (On-site)

Sanofi Group; Waterford; On-site; EUR 73,000 - 98,000; Full time

Job summary

Sanofi Waterford is seeking a Quality Control PCU Manager (Incoming and Device) for a 12-month FTC. You will oversee daily QC lab operations, ensure GMP-compliant processes, and manage validation and training within a fast-moving biopharma environment.

The role requires a science/engineering degree, strong leadership, and experience in manufacturing quality. You will contribute to CAPAs, investigations, and regulatory support from the Waterford site.

Qualifications

• Bachelor's degree in science, engineering, industrial engineering, or related discipline.
• Significant relevant experience in manufacturing quality; managerial experience is a plus.
• Strong leadership, analytical, problem-solving, and communication skills.
• Six Sigma or equivalent quality certification is advantageous.

Responsibilities

• Oversee daily QC laboratory operations to meet scheduled plans.
• Maintain GMP-compliant lab and processes per internal/external quality requirements.
• Ensure validated methods are used and transfer protocols executed as receiving unit.
• Manage and train laboratory staff following safety guidelines.
• Maintain lab qualification matrix to ensure testing readiness.
• Conduct routine shopfloor reviews to identify improvements.
• Ensure accurate and timely testing of received samples.
• Review and approve laboratory test results and reports.
• Maintain lab equipment through maintenance, qualification, calibration plans.
• Follow up on investigations, change controls, and CAPAs in timely manner.
• Investigate quality events and implement remediation actions.
• Support regulatory inspections and audits with QC-related responses.

Skills

Leadership

Analytical

Problem solving

Communication

Six Sigma

Education

Bachelor's degree in Science/Engineering

Job description

Sanofi Waterford is seeking a Quality Control PCU Manager (Incoming and Device) for a 12-month FTC. You will oversee daily QC lab operations, ensure GMP-compliant processes, and manage validation and training within a fast-moving biopharma environment.

The role requires a science/engineering degree, strong leadership, and experience in manufacturing quality. You will contribute to CAPAs, investigations, and regulatory support from the Waterford site.