QC Microbiology Manager

QCS Staffing Ltd; Cork; On-site; EUR 90,000 - 120,000; Full time

Job summary

QCS Staffing Ltd is seeking a QC Microbiology Manager for an 11-month contract in Cork, Ireland. You will lead the QC Microbiology team, ensuring cGMP compliance and timely testing with oversight of environmental monitoring and utilities.

The role requires expertise in regulatory expectations for microbiological control, strong leadership, and excellent communication. Experience with lean lab principles is preferred and the position is based at a state-of-the-art facility in Cork.

Qualifications

• Experience leading a QC microbiology team.
• Familiarity with FDA/EMA regulatory expectations for microbiological control and environmental monitoring.
• Strong written and verbal communication with a customer focus.
• Lean laboratory principles and continuous improvement experience preferred.

Responsibilities

• Lead the QC Microbiology team to operate in compliance with current cGMP standards and deliver results within timelines.
• Own the site environmental monitoring and utilities monitoring programmes, including routine execution, periodic review, quarterly reporting and trending.
• Oversee investigations for out-of-specification, out-of-trend and excursions, including root cause analysis and corrective actions.
• Oversee sterility testing program on site related to the Drug Product Facility onsite.

Skills

People management

Regulatory knowledge

Env monitoring

Aseptic processing

Communication

Job description

QC Microbiology Manager – Ireland, Cork – Initial 11-Month Contract – Life Sciences

Are you interested in joining a world leading biopharmaceutical company, focused on developing advanced and innovative treatments for those suffering with rare diseases? This is a fantastic opportunity to work in a state-of-the-art facility in Cork. You will be joining a leading Biopharmaceutical company who focus on a range of products which are life-changing for individuals. Our client is currently seeking a QC Microbiology Manager.

What You’ll Deliver

• Lead the QC Microbiology team to operate in compliance with current cGMP standards at all times, ensuring samples are tested and results delivered within specified timelines.
• Own the site environmental monitoring and utilities (water and compressed gases) monitoring programmes, including routine execution, periodic review, quarterly reporting and trending.
• Provide oversight of out-of-specification, out-of-trend and excursion investigations, including microbial identification, root cause analysis and documentation of corrective actions.
• Own and provide oversight for sterility testing program on site related to the Drug Product Facility onsite.

Key requirements

• Understanding and familiarity with FDA and European regulatory requirements, guidelines and expectations for microbiological control, environmental monitoring and aseptic processing.
• Previous experience of managing the performance of individual team members and of the overall team, including development and succession planning.
• Knowledge and experience of lean laboratory principles and continuous improvement is preferable.
• Excellent written and verbal communication skills, with a customer focus and ownership of the speed, quality and accuracy of delivery.