Quality Control Laboratory Manager

KellyOCG; Cork; On-site; EUR 90,000 - 120,000; Full time

Job summary

KellyOCG seeks a QC Microbiology Manager to lead the Shanbally site microbiology laboratory team. You will ensure testing under cGMP, oversee environmental monitoring, sterility testing, and actuarial investigations, while coordinating with QA, Manufacturing, Facilities and Regulatory Affairs.

The role requires strong leadership, initiative, and planning skills, with the ability to manage audits, CAPAs, and continuous improvement in a high-performance, multi-product environment.

Qualifications

• Experience managing a microbiology lab within cGMP regulatory frameworks.
• Proven ability to lead a multi-disciplinary team and coordinate with QA, Manufacturing, Facilities and Regulatory Affairs.
• Strong knowledge of environmental monitoring, sterility testing, deviation investigations and trend reporting.
• Excellent written and verbal communication, with ownership of delivery quality and timelines.

Responsibilities

• Lead the QC Microbiology team to operate in compliance with current cGMP standards and deliver results on time.
• Own the site environmental monitoring and utilities monitoring programmes, including quarterly reporting and trending.
• Oversee investigations for out-of-specification and out-of-trend results and document CAPAs.
• Manage the sterility testing programme supporting the Drug Product Facility.
• Coordinate external laboratories and suppliers and manage relationships.
• Develop the team in technical skills and lean laboratory practices.
• Plan resources against the manufacturing schedule and manage media and consumables.
• Represent QC Microbiology during regulatory inspections and audits.
• Author and review procedures, specs, reports, and change controls.
• Interface with QA, Manufacturing, Facilities, Regulatory Affairs, Supply Chain and external contractors.
• Participate in projects on QC Microbiology and contamination control strategies.
• Assist in budget planning for equipment, facilities, staffing and contracts.
• Identify training needs, conduct appraisals, and onboard staff.
• Act as designee for the Director, QC in their absence.

Skills

Regulatory knowledge

Leadership

Quality & compliance

Communication

Continuous improvement

Job description

The QC Microbiology Manager reports to the Head of QC and is responsible for leading the QC Microbiology laboratory team at the Shanbally site. The team delivers microbiological testing that supports the release and monitoring of drug substance and drug product, including anaerobic bioburden, environmental monitoring, water sampling, plate reading, growth promotion, and associated trending and reporting.

The successful candidate will lead within a high-performing, team-based organisation where colleagues are flexible, multi-skilled, and empowered to make decisions. A high level of initiative, energy, and motivation are key requirements, alongside strong organisational and planning skills.

The role requires technical expertise in microbiology and aseptic operations, combined with strong leadership capabilities. The position provides coordination and alignment between QC, QA, Manufacturing, Facilities, and Supply Chain to ensure microbiological testing and monitoring commitments are delivered in line with the site supply plan and quality objectives.

Key Responsibilities

• 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 the site sterility testing programme supporting the Drug Product Facility.
• Manage external microbial testing and relationships with external testing laboratories and suppliers.
• Develop the team in areas of technical expertise, operational excellence tools, and high-performance team behaviours, including standard work, 5S, and lean laboratory practices.
• Support laboratory equipment lifecycle management, service programmes, and new equipment introductions for the microbiology laboratory, along with method and equipment validation activities.
• Plan microbiology team resources and capacity against the manufacturing schedule and manage stocks of media, consumables, and reference cultures.
• Maintain the laboratory in an inspection-ready state and represent QC Microbiology during regulatory inspections, customer audits, and internal audits.
• Author, review, and approve procedures, protocols, specifications, reports, and change controls relating to microbiological testing and contamination control.
• Interface with Quality Assurance, Manufacturing, Facilities, Regulatory Affairs, Supply Chain, and external contractors and contract laboratories as required.
• Participate in project teams relating to QC Microbiology, contamination control strategy, and broader quality initiatives.
• Support budget preparation and monitoring, including capital equipment, facility requirements, staffing needs, and contract service requirements.
• Identify and deliver training for microbiology staff, prepare performance appraisals, and recruit and onboard team members.
• As required, act as designee for the Director, QC in their absence.
• Perform additional duties as assigned.

Required Experience & Skills

• Understanding and familiarity with FDA and European regulatory requirements, guidelines, and expectations for microbiological control, environmental monitoring, and aseptic processing.
• Previous experience managing individual and team performance, including employee development and succession planning.
• Knowledge and experience of lean laboratory principles and continuous improvement methodologies is desirable.
• Excellent written and verbal communication skills, with a strong customer focus and ownership of delivery quality, speed, and accuracy.
• Self-motivated, adaptable, and able to perform effectively in a growing, multi-product environment.