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 100 years, we continuously innovate to improve the diagnosis, prognosis and quality of life of patients.
Customer Centricity, Cooperation, Audacity, Focus, and Responsibility are the values that we share and practice on a daily basis.
Working at Guerbet is not only being part of a multicultural team with nearly 3,000 people across more than 20 countries, but it is above all about playing a unique role in the future of medical imaging.
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
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Establish and maintain an independent microbiology function aligned with site quality objectives.
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Manage and develop a team of microbiology professionals (approx. 12–15 analysts).
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Drive continuous improvement initiatives (e.g., Kaizen, Lean Sigma) within the department.
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Ensure compliance with GMP, FDA, USP, and other applicable regulatory standards.
Microbiological Testing & Data Management
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Manage performance of microbiological assays on raw materials, in-process samples, finished products, stability studies, environmental monitoring samples and packaging components.
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Oversee execution of microbiological testing protocols: sterility, bioburden, endotoxin, particulate matter, growth promotion, and the testing supporting environmental monitoring and personnel monitoring.
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Ensure accuracy and validity of all reported QC Microbiology test results.
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Utilize Laboratory Information Management Systems (LIMS) for microbiology data management.
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Perform monthly trend analysis of microbiological data to detect and address potential environmental or product quality concerns.
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Compile and analyze product related microbiology and environmental monitoring data for investigations, APQRs, KPIs, QMRs, and validation reports.
Technical Oversight & Issue Resolution
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Identify and investigate atypical results, instrument malfunctions, and methodology issues.
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Lead investigations into atypical results, out of specification events, and deviations; conduct proper root cause investigations and implement effective CAPAs.
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Ensure that microbiological method development and validation complies with regulatory requirements, Guerbet policies and site procedures.
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Execute special testing and validation protocols as needed.
Cross-Functional Collaboration:
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Schedule and coordinate Microbiology laboratory testing activities to support production schedule.
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Partner with Sterility Assurance to maintain robust contamination control and respond to sterility failures or environmental excursions.
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Lead microbiology-related investigations and support sterility assurance investigations as needed.
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Represent the microbiology department in cross-functional initiatives (e.g., Kaizen, Lean Sigma).
Strategic Compliance & Risk Management
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Maintain audit-ready conditions and represent microbiology during internal and external audits.
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Author and approve SOPs, test methods, specifications, and validation protocols.
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Participate as a core member of the Change Control Review Board to evaluate all changes for impact to the Microbiology Department, and to determine the support and resources necessary to successfully implement the change as scheduled.
Data Analysis & Reporting
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Perform trend analysis of microbiological data for APQRs, KPIs, and QMRs.
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Utilize LIMS and other validated digital tools for data integrity and reporting.
Training & Development
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Provide technical training and mentorship to staff.
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Train analysts on new and existing procedures, techniques, and regulatory requirements.
Performance Metrics (KPIs)
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Operational:
On-Time Testing Completion:- 95% of microbiological tests completed within defined turnaround times.
Environmental Monitoring Compliance:- 98% adherence to EM schedule and timely reporting of excursions.
Investigation Closure: Average time to close microbiology-related investigations- 30 days.
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Quality & Compliance:
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Audit Readiness: Zero critical observations related to microbiology during internal/external audits.
CAPA Effectiveness:- 90% of microbiology-related CAPAs verified as effective within agreed timelines.
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Data Integrity: 100% compliance with ALCOA+ principles in microbiology documentation.
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Leadership & Development:
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Training Completion: Ensure 100% on-time completion of annual microbiology training by active team members, and employee qualifications per SOPs are maintained as scheduled.
Competency: Maintain- 95% competency scores for microbiology analysts during annual assessments.
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Continuous Improvement:
Deviation Reduction: Achieve- 25% year-over-year reduction in repeat microbiology-related deviations through effective root cause analysis.
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Method Robustness: Implement at least 2 method improvements or validations annually to enhance accuracy and reduce repeat testing.
Laboratory Efficiency and Throughput: Reduce average turnaround time for microbiological test results by- 5% year-over-year.
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Process Optimization: Lead a minimum of 2 lab-focused continuous improvement projects per year.
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Performs other duties as assigned by management.
Department Specific/Non-Essential Functions:
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Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment.
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Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk.
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Report all safety and/or environmental incidents, unsafe conditions or near misses to management immediately.
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Proper PPE must be worn at all times in laboratory and production areas.
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Proactively manage and maintain regulatory compliance (US/EU/WHO/Brazilian/Korean standards).
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Performs other duties as assigned by management
YOUR BACKGROUND
Education, Experience, and/or Skill:
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Education: Bachelor’s degree in Microbiology (advanced degree preferred).
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Experience:
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Minimum 10 years of hands-on microbiology laboratory experience in a regulated pharmaceutical manufacturing environment.
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Minimum 3 years in a leadership role managing microbiology operations.
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Skills:
- Strong leadership, organizational, and communication skills.
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In-depth knowledge of GMP, FDA, USP, and global regulatory standards.
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Proficiency in data analysis and laboratory information systems.
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Experience with systems used in manufacture of GMP finished goods including QMS, LIMS, CMMS, ERP, etc. (hands on knowledge of SAP strongly preferred).
Physical Requirements:
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Ability to lift or move objects, such as laboratory equipment and sample, up to 50lbs. without assistance
Cognitive Requirements:
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Ability to manage projects with multiple functional groups without direct reporting authority
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Strong communication and interpersonal skills
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Ability to analyse tasks, events, problems, or strategies from a Cost of Quality perspective
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Getting work done through others that are not direct reports
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Operates with minimal direction, self-starter
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Building relationships with other departments
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Presentation skills
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Statistical Analysis capability
