Manager, Quality Control (Microbiology)

Job Description

The Microbiology QC Manager at our Dundalk facility supports the site through the strategic start-up, qualification and routine operational management of the full suite of QC microbiology programs and laboratories. The role ensures the timely, compliant execution of environmental monitoring, utility testing and microbiological assays (bioburden, endotoxin and sterility) to support drug substance and drug product manufacturing. This leader manages, coaches and mentors the QC Micro team while aligning testing capabilities with global corporate standards and regulatory guidelines.

Bring energy, knowledge, innovation to carry out the following:

• Laboratory Management:
  • Direct the daily operations of the QC Microbiology laboratories, ensuring all testing (EM, WFI/Utilities, Bioburden, Endotoxin and Sterility) is executed safely, compliantly and in accordance with laboratory timelines
• People Leadership:
  • Recruit, manage, coach and mentor a high-performing team of QC Micro specialists, analysts and technicians
  • Foster a strong culture of quality, inclusion and professional development
• Contamination Control Strategy (CCS) Support:
  • Serve as a key stakeholder and technical contributor to the site-wide Contamination Control Strategy, partnering with Sterile Operations, Engineering and Quality Assurance to analyse environmental risks, evaluate trending data and align site controls with Annex 1
• Review and Approval:
  • Review and approve GMP documentation, including validation protocols/reports for microbiology methods, monthly/quarterly EM trend reports and critical microbiology deviations and CAPAs
• Resource and Budget Planning:
  • Apply project management concepts to manage lab resources, headcount, equipment purchase, vendor contracts and laboratory consumable spend
• Audit Representation:
  • Represent the QC Microbiology department as the principal lead during major regulatory agency inspections and internal corporate audits
• Cross-Functional Tiers:
  • Actively participate in the site operational Tier structure, aligning QC Micro activities with production, engineering and supply chain schedules to prevent product release delays

What skills you will need:

In order to excel in this role, you will more than likely have:

• B.Sc. or M.Sc. degree in Microbiology, Biological Sciences or equivalent
• Approximately 7 years of laboratory experience in the pharmaceutical or biotechnology sector, with at least 3 years in a direct management, supervisory or people-leadership role within a QC Microbiology laboratory
• Strong background in managing environmental monitoring program, microbiological testing operations and clean utility monitoring programs
• Experience leading and managing qualification of microbiological methods and commercial launch readiness
• Exceptional leadership, coaching and team-building skills, with a track record of building diverse, high-performing technical teams
• Advanced strategic knowledge of global regulatory expectations (Annex 1, FDA, HPRA, JP, WHO) for sterile drug products and biologics
• High proficiency in risk management, critical decision-making and conflict resolution while adhering to scheduled timelines
• Strong verbal and written communication skills, with the ability to summarize complex microbiological trends for site executive leadership
• Strategic thinker with the ability to manage long-term projects (e.g., lab digitalization) alongside daily operational priorities

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, please apply today.

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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