Lead QC Microbiology Team - Drive GMP Excellence

PSC Biotech® Corporation; Munster; On-site; EUR 90,000 - 120,000; Full time

Job summary

PSC Biotech Corporation in Ireland invites an experienced QC Microbiology Manager to lead the site microbiology laboratory, ensuring cGMP-compliant testing and timely results. You will drive environmental monitoring, validate sterility procedures, and mentor a high-performing team to uphold quality and regulatory readiness.

You will coordinate with QA, Manufacturing, Regulatory Affairs, and Supply Chain to align microbiology activities with the site plan and customer expectations, while guiding

Qualifications

• Knowledge of FDA and European regulatory expectations for microbiological control and environmental monitoring.
• Experience managing a microbiology team with development and succession planning.
• Familiarity with lean laboratory principles and continuous improvement.

Responsibilities

• Lead the QC Microbiology team to operate under current cGMP standards and deliver results on time.
• Own environmental monitoring and utilities monitoring programs with periodic reporting and trending.
• Oversee investigations for out-of-specification and out-of-trend results and document corrective actions.
• Manage sterility testing program on site for the Drug Product Facility and liaise with external labs.
• Develop the team in technical expertise and apply standard work and 5S/lean practices.
• Coordinate with QA, Manufacturing, Facilities, Regulatory Affairs and Supply Chain to align testing with the site plan.

Skills

Regulatory compliance

People management

Microbiology

Aseptic processing

Lean laboratory

cGMP standards

Job description

PSC Biotech Corporation in Ireland invites an experienced QC Microbiology Manager to lead the site microbiology laboratory, ensuring cGMP-compliant testing and timely results. You will drive environmental monitoring, validate sterility procedures, and mentor a high-performing team to uphold quality and regulatory readiness.

You will coordinate with QA, Manufacturing, Regulatory Affairs, and Supply Chain to align microbiology activities with the site plan and customer expectations, while guiding