QC Microbiology Manager (Sterile Drug Production)

31 Joo Koon

Apply via our career portal: https://jobs.thermofisher.com/global/en/job/TFSCGLOBALR01297777EXTERNALENGLOBAL/Manager-QC-Microbiology

In the role of QC Manager (Microbiology) at Thermo Fisher Scientific Inc., you will be responsible for leading all aspects of Quality Control operations. This includes ensuring regulatory compliance, data integrity, and adherence to corporate standards. You will also collaborate with other site functions to provide expertise in biologic microbiology method qualification and validation strategies.

• Implement and promote the safety message as the top priority for all employees in the organization, and reinforce it across the facility.
• Ensure compliance with Health Authority regulations.
• Collaborate with Sr. Quality Control Manager, Quality Director, and site leadership to improve the Quality Culture.
• Prepare and manage the Quality Control laboratory budget, implementing cost control measures.
• Ensure comprehensive training of personnel in skills, cGMP, and Safety.
• Lead internal audits, regulatory inspections, and customer audits.
• Ensure timely testing, sampling, and release of microbial tests.
• Conduct routine monitoring of classified environments, purified water, process air, and clean utilities.
• Coordinate daily microbiological laboratory activities to align with cGMP and company standards.
• Lead QC groups and support biologics manufacturing, including product testing and system validations.
• Ensure complete and compliant testing to meet production schedules.
• Manage lab documentation, critical reagents, and microbiological cultures.
• Establish and maintain a microbiological laboratory management system.
• Identify and address gaps in compliance with updated regulations.
• Support facility microbial control strategies and coordinate lab investigations and reports.
• Lead laboratory investigations, deviations, and timely closures.
• Support sterility assurance and aseptic process control.
• Report metrics, track schedules, and ensure adherence to timelines.
• Ensure data integrity principles are applied throughout QC processes.
• Hire, develop, and manage professionals within the Quality Control Microbiology group, providing feedback, mentoring, and opportunities for growth.

Education:

• University degree in chemistry, biochemistry, or life sciences, or equivalent experience

Experience:

• 10 years in the pharmaceutical or medical devices industry, Quality Control
• 6 years in a regulated pharmaceutical QC Microbiology laboratory, 4 years of supervisory or management experience

Skills:

• Knowledge of cGMP environment and regulatory expectations
• Technical expertise in QC microbiology and analytical instrumentation
• Strong interpersonal and communication skills in English
• Understanding of applicable regulatory requirements
• Ability to work cross-functionally to meet timelines and objectives
• Experience in Health Agency/internal audits