QC Microbiology Manager

Guerbet; Raleigh (NC); On-site; USD 120,000 - 170,000; Full time

Job summary

Guerbet is seeking a QC Microbiology Manager to lead all site microbiology activities, ensuring compliance with GMP, FDA, and USP standards. You will manage a team of 12–15 analysts, collaborate with Sterility Assurance, manufacturing, engineering, and QA to sustain a robust contamination control strategy.

The role emphasizes leadership, data integrity, and continuous improvement within a regulated pharmaceutical environment, with responsibilities spanning testing, documentation, and

Qualifications

• Bachelor’s degree in Microbiology.
• Minimum 10 years of hands-on microbiology lab experience in a regulated pharmaceutical environment.
• Minimum 3 years in a leadership role managing microbiology operations.
• Strong knowledge of GMP, FDA, USP and global standards.

Responsibilities

• Lead microbiology laboratory operations and a team of analysts.
• Oversee microbiological testing of raw materials, in-process samples, finished products and environmental monitoring.
• Ensure data integrity, validated methods, and timely reporting using LIMS and associated systems.
• Drive CAPA investigations and root-cause analysis for deviations and OOS events.
• Collaborate with Sterility Assurance, Manufacturing and QA to maintain contamination control.

Skills

Leadership

GMP Knowledge

Data analysis

Communication

Project management

Education

Bachelor’s degree in Microbiology

Tools

LIMS

QMS

SAP

CMMS

ERP

Job description

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 Management

• Maintain audit-ready conditions and represent microbiology during internal and external audits.
• Author and approve SOPs, test methods, specifications, and validation protocols.
• 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

• Perform trend analysis of microbiological data for APQRs, KPIs, and QMRs.
• Utilize LIMS and other validated digital tools for data integrity and reporting.

Training & Development

• Provide technical training and mentorship to staff.
• Train analysts on new and existing procedures, techniques, and regulatory requirements.
• 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.
• Quality & Compliance:
• 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.
• Data Integrity: 100% compliance with ALCOA+ principles in microbiology documentation.
• Leadership & Development:
• Training Completion: Ensure 100% on-time completion of annual microbiology training by active team members, and employee qualifications per SOPs are maintained as scheduled.
• Deviation Reduction: Achieve ≥ 25% year-over-year reduction in repeat microbiology-related deviations through effective root cause analysis.
• 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.
• Process Optimization: Lead a minimum of 2 lab-focused continuous improvement projects per year.
• Performs other duties as assigned by management.

Department Specific/Non-Essential Functions:

• Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment.
• Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk.
• Report all safety and/or environmental incidents, unsafe conditions or near misses to management immediately.
• Proper PPE must be worn at all times in laboratory and production areas.
• Proactively manage and maintain regulatory compliance (US/EU/WHO/Brazilian/Korean standards).
• Performs other duties as assigned by management

YOUR BACKGROUND

Education, Experience, and/or Skill:

• Education: Bachelor’s degree in Microbiology (advanced degree preferred).
• Experience:
• Minimum 10 years of hands-on microbiology laboratory experience in a regulated pharmaceutical manufacturing environment.
• Minimum 3 years in a leadership role managing microbiology operations.
• Skills:
• Strong leadership, organizational, and communication skills.
• In-depth knowledge of GMP, FDA, USP, and global regulatory standards.
• Proficiency in data analysis and laboratory information systems.
• Experience with systems used in manufacture of GMP finished goods including QMS, LIMS, CMMS, ERP, etc. (hands on knowledge of SAP strongly preferred).

Cognitive Requirements:

• Ability to manage projects with multiple functional groups without direct reporting authority
• Strong communicationand interpersonal skills
• Abilitytoanalysetasks, events,problems,or strategies from aCost of Qualityperspective
• Getting work done through others that are not direct reports
• Operates with minimal direction, self-starter
• Building relationships with other departments
• StatisticalAnalysiscapability

Reason to join US

Much more than a Competitive salary,

We offer continued personal development. When you join Guerbet, you :

• Are choosing a global leader with recognized expertise in diagnostic and interventional imaging,
• Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient’s life all over the world,
• Are joining a company where we value diversity of talents coming from various horizon.

We # Innovate # Cooperate # Care #Achieve at Guerbet.

Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. Guerbet is committed to diversity, equity, and inclusion.

Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to [e-mail] or you can also call this number+19843443717