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Manager, QC Microbiology

Location Singapore, Singapore Job Id R-01297777 Job Type Full time Category Quality & Regulatory Remote Fully Onsite

The Quality Difference at Thermo Fisher Scientific: What makes our quality teams unique is a shared passion for getting it done right the first time and working for the right reasons with our customers always in mind. Our team of Quality professionals understand our customers rely on the accuracy, safety, and effectiveness of our products and services that are improving lives around the world. When you join our team of quality professionals, you’ll collaborate on projects on a global scale while being encouraged to grow your skills and discover new career paths with us.
JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Position Summary

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.

Responsibilities

  • 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.

Minimum Requirements/Qualifications

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

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"Quality is everyone's responsibility. Right the first time should not be only a metric, but a lifestyle."


Elaine
Director, Regulatory Affairs,
Latin America, Specialty Diagnostics

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