Senior QC Microbiology Lab Leader

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

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.