QC Manager – Microbiology (Singapore)

About the role

We are seeking a highly motivated Quality Control Manager (Microbiology) to join our team and play a key role in establishing and operating a state-of-the-art QC laboratory at our new Singapore site. This position offers an exciting opportunity to contribute to the successful start-up of a new facility and ensure compliance with global quality standards.

Key responsibilities

• Lead and manage day-to-day operations of the Microbiology team, ensuring performance and compliance with cGMP, HSE and regulatory requirements.
• Plan, execute and continuously improve microbiological testing activities including bioburden, endotoxin, environmental monitoring and water testing.
• Provide leadership, coaching and development to QC analysts.
• Investigate and resolve Out-of-Spec (OOS) results, deviations and CAPAs in a timely manner.
• Collaborate with Manufacturing, Quality Assurance and Regulatory Affairs to support batch release and regulatory submissions.
• Promote operational excellence and continuous improvement within the QC microbiology team.
• Monitor and report KPIs, ensuring targets for quality, safety and productivity are met.
• Ensure laboratory equipment, methods and systems are qualified, validated and maintained in compliance.
• Support internal and external audits and regulatory inspections.

Required profile

• Degree in Microbiology, Life Sciences or a related scientific discipline.
• 10-12 years of experience in a pharmaceutical or biopharmaceutical microbiology laboratory, including people-management experience.
• Proven ability to work collaboratively in a fast-paced environment.

Required skills

• Microbiological testing methods (bioburden, endotoxin, environmental monitoring, water testing).
• cGMP regulations (EU/US) and quality management systems.
• Equipment qualification and validation.
• Quality Management, Risk-Based Approach, Operational Excellence and Safety Management.