Microbiology Manager

CareerWise Recruitment; Galway; On-site; EUR 90,000 - 130,000; Full time

Job summary

CareerWise Recruitment seeks a Microbiology Laboratory Manager to lead the Galway-based microbiology lab, ensuring product safety and regulatory compliance. You will oversee microbial testing for release, maintain GLP/GMP adherence, and drive data validity and audit readiness.

The role requires strong leadership, strategic planning, and cross-functional collaboration to meet regulatory requirements and company standards.

Qualifications

• Level 8 degree and experience in FDA/IMB regulated facilities.
• Knowledge of aseptic processing and environmental monitoring.
• Proven leadership with track record of delivering results.
• Strong communication and cross-functional collaboration.

Responsibilities

• Lead and oversee microbial testing of pharmaceutical products for release.
• Ensure GLP, GMP compliance and regulatory directives.
• Maintain safe, efficient lab operations and valid data generation.
• Establish and audit test methods; drive audits readiness.
• Manage microbiology team including coaching and training.
• Support continuous improvement initiatives such as 6S/Lean.
• Contribute to regulatory files for new product submissions.

Skills

Leadership

Regulatory knowledge

Quality management

Project management

Team development

Communication skills

Environmental Monitoring

Education

Level 8 Degree

Job description

The Microbiology Laboratory Manager will be lead and oversee the Galway Based Microbiology Laboratory to ensure product safety and reliability, ensuring that all qualify and regulatory requirements are met.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Manage and control the microbial testing of pharmaceutical products for release.
• Ensure highest quality standards are maintained in areas of responsibility and that industry best practice is adopted in accordance with current GLP, GMP and regulatory body directives.
• Ensure all laboratory analysis is carried out in a safe, efficient and timely manner and ensure that systems and methods of analysis, sampling and testing are in place to allow for the generation of valid data.
• Ensure validity of all test methods in the laboratory are established and documented.
• Interact efficiently with other department managers/ directors.
• Ensure department readiness for audits both internal and external authorities. Represent Quality management for Microbiology and interface with investigators during these inspections.
• Manage and support the Microbiology Team..... including establishing employee goals and objectives, assess performance, provide regular feedback, coach, develop and ensure dept. personnel are properly trained and remain in compliance with training requirements at all times.
• Support continuous improvement projects such as 6S and lean processes for the laboratory.
• Provide input to regulatory files in support of new product submissions and approvals.
• Maintain safety requirements.

QUALIFICATIONS & REQUIREMENTS

• Level 8 Degree
• Knowledge of working within an FDA/IMB regulated facility.
• Knowledge of Aseptic Processing.
• Knowledge of Monitoring and Management of the Microbial Environment.
• Ability to set clear goals and development plans for team, communicate these clearly and ensure progress to completion meeting predefined targets.
• Track record of showing how results were delivered through management/leadership of others.
• Ability to provide leadership, Project management, resource planning and budgeting.
• Development and training of team members.
• Excellent communication skills (verbal and written).
• Ability to work cross functionally with other departments (Analytical, Quality, Manufacturing and Regulatory).
• Working knowledge of isolator technology.
• Working knowledge of Environmental Monitoring of a Pharmaceutical Manufacturing Environment