QC Microbiology Manager

Job Description: QC Microbiology Manager

Our client is a leading global biopharmaceutical organisation with a major manufacturing facility in South Dublin. Due to the continued expansion of manufacturing operations at the site, they are seeking an experienced QC Microbiology Manager to support microbiology readiness, laboratory capability development and the transition into routine operations.

The QC Microbiology Manager will play a key role in establishing the people, processes, systems and laboratory capabilities required to support the expansion of manufacturing operations. The successful candidate will lead and coordinate QC Microbiology readiness activities while working closely with Quality, Manufacturing, Engineering and other cross-functional stakeholders.

The position will initially operate on a day-based working pattern, with flexibility required to support or transition to a 16/5 working arrangement depending on future operational requirements. As business needs evolve, the role may also assume responsibility for QC Microbiology operational teams and activities.

Key Responsibilities:

• Lead and coordinate QC Microbiology readiness activities associated with the expansion of manufacturing operations.
• Develop and execute readiness plans in advance of future operational requirements.
• Support the development, review and implementation of GMP documentation, including SOPs, protocols, reports and other controlled documentation.
• Support the definition, procurement, qualification and implementation of microbiology laboratory equipment, consumables and media.
• Coordinate resource, training and qualification plans to ensure QC Microbiology personnel are prepared for future operations.
• Provide microbiology expertise within cross-functional project teams and represent the QC Microbiology function at relevant project and operational forums.
• Work closely with Quality, Manufacturing, Engineering and other stakeholders to ensure microbiological requirements are incorporated into project and operational planning.
• Support the establishment, implementation and maintenance of Environmental Monitoring and other microbiological testing programmes.
• Supervise and manage QC Microbiology personnel as required, providing effective coaching, development and technical leadership.
• Ensure QC Microbiology activities are performed safely and in accordance with applicable GMP requirements, procedures and registered specifications.
• Develop and maintain quality systems within the QC Microbiology function to ensure ongoing compliance and inspection readiness.
• Provide an effective and efficient QC Microbiology service to operations, with a strong focus on Right First Time, compliance and continuous improvement.
• Support the timely investigation and resolution of laboratory investigations, deviations, non-conformances and other quality events.
• Review microbiological and Environmental Monitoring data to identify trends and opportunities for further development and improvement.
• Keep up to date with current regulatory, corporate and industry requirements relating to microbiology, laboratory operations and aseptic manufacturing.
• Review and approve SOPs, investigations, non-conformances, validation and qualification protocols and reports, microbiological trend data, method validations and verifications, and equipment qualification documentation.
• Participate in regulatory agency inspections and internal audits as required.
• Develop and implement procedures and systems to maximise operating efficiency and support the successful transition of project activities into routine operations.
• Manage and contribute to departmental productivity, quality and compliance objectives.
• Support wider QC Microbiology operational activities as required.

Skills & Experience:

• Broad technical knowledge of pharmaceutical microbiology and QC laboratory operations.
• Strong understanding of GMP requirements applicable to microbiological testing and aseptic manufacturing.
• Previous experience working within a GMP-regulated pharmaceutical or biopharmaceutical environment.
• Experience supporting Environmental Monitoring and other microbiological testing programmes.
• Understanding of the cross-functional dependencies between QC Microbiology, Manufacturing, Quality, Engineering and other supporting functions.
• Ability to understand business and project objectives and translate them into practical QC Microbiology requirements.
• Knowledge of current industry and regulatory expectations relating to microbiological control and laboratory operations.
• Experience leading cross-functional teams is desirable.
• Previous experience supervising or managing QC Microbiology personnel would be beneficial.
• Project management experience or demonstrated ability to manage complex programmes of work would be advantageous.
• Experience developing, reviewing and approving GMP documentation.
• Strong analytical skills with the ability to evaluate and interpret complex technical and operational situations.
• Ability to identify risks early and develop appropriate mitigation strategies.
• Ability to develop practical solutions, procedures and processes to achieve the required outcomes.
• Capable of managing multiple assignments, priorities and processes simultaneously.
• Comfortable working independently against both operational and project objectives.
• Strong communication, leadership and stakeholder management skills.
• Experience participating in regulatory inspections or internal audits would be advantageous.
• Experience with microbiology laboratory equipment qualification, method validation or verification, and the training and qualification of laboratory personnel would be beneficial.

Contract Information:

• Rate: TBC, dependent on the level of skills and expertise of the candidate.
• Start Date: To be confirmed.
• Length of Contract: 12 months.
• Schedule: Full-time and fully onsite. The role will initially operate on a day-based schedule, with flexibility to support or transition to a 16/5 working pattern depending on future business and operational requirements.
• Location: South Dublin.
• Work Authorisation: Candidates must be authorised to work in Ireland without sponsorship.

Please note that candidate details and CVs will not be forwarded to our clients without the candidate's prior knowledge and consent.