Laboratory Manager

JOB TITLE

Laboratory Manager

DEPARTMENT

Quality

REPORTING TO

Head of Quality

Individual Contributor or People Manager

People Manager

OBJECTIVES OF POSITION

• Provide final review and approval of results, protocols, reports, SOP's etc.
• To act as the primary laboratory point person accountable for the team achieving a continually high standard of work.
• This role functions as a Subject Matter Expert (SME) to coordinate scheduling, deliver compliant products on time, and create a work environment that supports team effectiveness through coaching and mentoring.

RESPONSIBILITIES

• Maintain regulatory compliance through established programs for lab testing, environmental control, training, SOP's, technical investigations, test method validation and cleaning in a medical device regulated environment.
• Develop and maintain quality systems within the laboratory to ensure ongoing compliance to cGMP
• Compliance with Standard Operating Procedures and Registered specifications.
• Ensure timely completion of Laboratory Investigation Reports and deviations through the Non-Conformance procedures.
• Issue trend reports on investigations, non-conformances.
• Keeps abreast of current Corporate and industry requirements and compliance trends as they pertain to laboratory operations.
• Approval of SOP's, trend data, investigations, deviations, validation protocols, reports, method validation/verifications and equipment qualifications.
• Participate in regulatory agency inspections.
• Plan and implement procedures and systems to maximise operating efficiency.
• Manage and contribute to the achievements of department productivity and quality goals.
• Manage the scheduling and control of product testing to ensure output targets are achieved.
• Review and authorize records for product disposition in accordance with cGMP and defined procedures.
• Coordinate testing and analysis of batches to meet customer expectations.
• Oversee and sign off on out-of-specification investigations.
• Act as the primary point of contact and SME for audits and inspections.
• Monitor and assist hands-on in daily laboratory activities.
• Ensure the laboratory is maintained in a clean, audit-ready condition with sufficient consumables.
• Liaise with the Department Manager regarding recruitment and resource planning.
• Ad hoc duties as assigned by area Manager

Quality

• Assure ongoing compliance with quality and industry regulatory requirements
• Proactively prevent or reduce non-conformances and support CAPA/change control processes.
• Ensure local quality requirements are considered for new or changed laboratory methods.

Health & Safety

• Ensure compliance with Health & Safety Legislation and Regulations.
• Generate and maintain risk assessments for the laboratory area.
• Promote safety awareness and proactively reduce hazards and risks within the lab.

MEASUREMENTS

• Achievement of output targets and delivery of quality products on time.
• Audit readiness and successful outcomes of quality/compliance inspections.

PERSONNEL SPECIFICATIONS Qualifications and Experience

• NFQ Level 8 Degree in Microbiology or associated Life Science discipline.
• 5+ years microbiology work experience, ideally the majority of which in a FDA regulated environment.
• 2 years team lead / people management experience in microbiology testing within the laboratory is required, including conducting performance reviews.
• Experienced in lead the training & development of micro analysts.
• Experienced in the calibration and use of laboratory instrumentation, including troubleshooting equipment when problems arise.
• Excellent communication and presentation skills.
• Minimum 1 year of experience in a product testing environment with analytical instruments.
• Previous supervisory or leadership experience is preferred to lead and develop a team in a regulated environment.
• Experience running and maintaining a laboratory to GLP standards is preferred.
• Working knowledge of cGMP, EHS, and applicable regulatory standards.

Core Competencies

• High attention to detail, ensures accuracy in testing and documentation.
• Strong organizational and practical skills with the ability to manage changing priorities.
• Proactive and accountable mindset regarding quality, efficiency, and safety.
• Strong communication and interpersonal skills for stakeholder alignment and handovers.