QC Microbiology Manager

At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.

 

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.

 

Achieve, Cooperate, Care and Innovate are the values ​​that we share and practice on a daily basis.

 

Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.

 

For more information on Guerbet, go to www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube

 

WHAT WE ARE LOOKING FOR

The QC Microbiology Manager operates in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization’s framework, company’s procedures, and the defined scope of responsibility the role is accountable for.

The QC Microbiology Manager leads all site microbiological control activities, ensuring compliance with global regulatory standards and internal quality systems. This role oversees microbiological testing for raw materials, in process samples, finished products, and environmental monitoring, supporting both aseptic and terminal sterilization processes. The manager partners closely with Sterility Assurance, manufacturing, validation, engineering, and Quality Assurance to maintain a robust contamination control strategy. Responsibilities include managing daily laboratory operations, guiding laboratory staff, ensuring timely and accurate testing, and maintaining compliant documentation, data integrity, and validated methods.

YOUR ROLE

Essential Functions & Responsibilities:

Leadership & Department Oversight

• Establish and maintain an independent microbiology function aligned with site quality objectives.
• Manage and develop a team of microbiology professionals (approx. 12–15 analysts).
• Drive continuous improvement initiatives (e.g., Kaizen, Lean Sigma) within the department.
• Ensure compliance with GMP, FDA, USP, and other applicable regulatory standards.

Microbiological Testing & Data Management

• Manage performance of microbiological assays on raw materials, in-process samples, finished products, stability studies, environmental monitoring samples and packaging components.
• Oversee execution of microbiological testing protocols: sterility, bioburden, endotoxin, particulate matter, growth promotion, and the testing supporting environmental monitoring and personnel monitoring.
• Ensure accuracy and validity of all reported QC Microbiology test results.
• Utilize Laboratory Information Management Systems (LIMS) for microbiology data management.
• Perform monthly trend analysis of microbiological data to detect and address potential environmental or product quality concerns.
• Compile and analyze product related microbiology and environmental monitoring data for investigations, APQRs, KPIs, QMRs, and validation reports.

Technical Oversight & Issue Resolution

• Identify and investigate atypical results, instrument malfunctions, and methodology issues.
• Lead investigations into atypical results, out of specification events, and deviations; conduct proper root cause investigations and implement effective CAPAs.
• Ensure that microbiological method development and validation complies with regulatory requirements, Guerbet policies and site procedures.
• Execute special testing and validation protocols as needed.

Cross-Functional Collaboration:

• Schedule and coordinate Microbiology laboratory testing activities to support production schedule.
• Partner with Sterility Assurance to maintain robust contamination control and respond to sterility failures or environmental excursions.
• Lead microbiology-related investigations and support sterility assurance investigations as needed.
• Represent the microbiology department in cross-functional initiatives (e.g., Kaizen, Lean Sigma).

Strategic Compliance & Risk M