Manager, Quality Control (Microbiology)

MSD Ireland; Leinster; On-site; EUR 90,000 - 130,000; Full time

Job summary

MSD Ireland in Dundalk seeks a Microbiology QC Manager to lead start-up, qualification and routine management of QC microbiology programs. You will oversee environmental monitoring, bioburden, endotoxin and sterility testing to support drug substance and product manufacturing.

You will coach and develop the QC Micro team, align testing with global standards, review GMP docs, and manage budgets while collaborating with QA, Engineering and Operations for site-wide quality and compliance.

Qualifications

• Bachelors or Masters in Microbiology or Biological Sciences (or equivalent).
• Experience in pharmaceutical/biotech QC microbiology environments.
• Strong leadership and communication capabilities.

Responsibilities

• Direct daily operations of QC Microbiology laboratories (EM, endotoxin, bioburden, sterility) ensuring safety, compliance and timelines.
• Recruit, coach and mentor a high-performing QC Micro team with emphasis on quality culture.
• Contribute to sitewide Contamination Control Strategy and regulatory alignment.
• Review and approve GMP documentation including validation protocols and CAPAs.
• Manage lab resources, budgets, equipment and vendor contracts.

Education

B.Sc./M.Sc. in Microbiology or Biological Sciences or equivalent

Job description

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,

Required Skills

• Bioburden Testing
• Biological Indicators
• Budget Planning
• Coaching
• Contamination Control
• Endotoxin Testing
• Environmental Monitoring
• Leadership
• Microbiological Test
• Risk Management
• Sterility Testing
• Team Performance Management

Employee Status

Regular

Flexible Work Arrangements

Not Applicable

Job Posting End Date

09/19/2026

• A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID

R414424