Manager, Quality Control (Microbiology)

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

Job summary

MSD in Ireland seeks a Microbiology QC Manager to lead the site QC Microbiology laboratories, guiding environmental monitoring, bioburden, endotoxin and sterility testing in support of drug substance and product manufacturing.

The role involves people leadership, strategy development for contamination control, and ownership of GMP documentation, audits and budget planning to ensure timely, compliant operations.

Qualifications

• B.Sc. or M.Sc. degree in Microbiology, Biological Sciences or equivalent.
• Approximately 7 years of laboratory experience in pharma/biotech, with at least 3 years in a direct management or leadership role within QC Microbiology.

Responsibilities

• Direct the daily operations of the QC Microbiology laboratories, ensuring testing is safe, compliant and timely.
• Recruit, manage, coach and mentor a high-performing QC Micro team.
• Support Contamination Control Strategy by analyzing environmental risks and trends.
• Review and approve GMP documentation, validation protocols, and EM trend reports.
• Manage lab resources, headcount, equipment purchases and consumables spend.
• Represent QC Micro during regulatory inspections and internal audits.
• Coordinate QC Micro activities with production, engineering and supply chain to prevent delays.

Skills

Bioburden Testing

Biological Indicators

Budget Planning

Coaching

Contamination Control

Endotoxin Testing

Environmental Monitoring

Leadership

Microbiological Test

Risk Management

Sterility Testing

Team Performance Management

Education

B.Sc. or M.Sc. in Microbiology

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.

Employee Status

Regular

Flexible Work Arrangements

Not Applicable

Job Posting End Date

09/10/2026

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

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