QC Manager, Microbiology

Sanofi; Singapore; Vor Ort; SGD 150.000 - 190.000; Vollzeit

Zusammenfassung

Sanofi seeks a Quality Control Manager (Microbiology) to lead the new Singapore QC lab ahead of facility start-up. You will manage the microbiology team, ensure cGMP compliance, and support regulatory submissions while driving continuous improvement across testing areas.

Role requires 10–12 years in pharma microbiology, strong leadership, and English proficiency. Based at Tuas site, you will collaborate with Manufacturing, QA, and Regulatory Affairs to ensure timely batch release and audits.

Qualifikationen

• Degree in Microbiology or Life Sciences with relevant certification is required.
• About 10–12 years in pharmaceutical/biopharmaceutical microbiology labs.
• Experience managing people in a fast-paced setting.
• Strong knowledge of microbiological testing methods and quality systems.
• Fluent English with excellent communication and leadership skills.

Aufgaben

• Lead Microbiology team operations ensuring cGMP, HSE, and regulatory compliance.
• Plan, perform, and improve microbiological testing (bioburden, endotoxin, EM, water).
• Coach and develop QC analysts; manage performance and succession.
• Investigate OOS, deviations, and CAPAs; ensure timely resolutions.
• Collaborate with Manufacturing, QA, and Regulatory to support batch release.
• Drive Operational Excellence and continuous improvement within QC microbiology.
• Monitor KPIs for quality, safety, and productivity; report outcomes.
• Ensure equipment, methods, and systems are qualified and validated.

Kenntnisse

Leadership

Communication

Team management

Cross-functional collaboration

Quality Management

Risk-Based Approach

Operational Excellence

Safety Management

Ausbildung

Degree in Microbiology/Life Sciences

Jobbeschreibung

Job title: QC Manager, Microbiology

• Grade: L2-2

• Hiring Manager: Head of Site Quality Control

• Location: Tuas, Singapore

About the job:

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Sanofi has added two new Modulus Facilities to our global industrial footprint. These production units represent the future of manufacturing. They allow us to increase our capacities while making production more flexible and respectful of the environment.

Fully digitalized, our Modulus Facilities will enable more responsive and flexible manufacturing across multiple vaccine and biological platforms including mRNA, while minimize our impact to the environment. Our facilities will help improve people’s lives by giving them faster access to more treatments.

In this context, 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.

Main Responsibilities

• Lead and manage the day-to-day operations of the Microbiology team, ensuring performance and compliance with cGMP, HSE, and regulatory requirements

• Drive consistent planning, execution, and improvement of microbiological testing activities including bioburden, endotoxin, environmental monitoring, and water testing

• Provide strong leadership, coaching, and development to a team of QC analysts

• Ensure timely investigation and resolution of Out-of-Specification (OOS) results, deviations, and CAPAs

• Collaborate cross-functionally with Manufacturing, Quality Assurance, and Regulatory Affairs to support batch release and regulatory submissions

• Champion a culture of Operational Excellence and continuous improvement within the QC microbiology team

• Monitor and report on the team’s KPIs, ensuring targets for quality, safety, and productivity are met

• Ensure all laboratory equipment, methods, and systems are qualified, validated, and maintained in a state of compliance

• Support internal and external audits and regulatory inspections

About You

Education and experience

• Education: Degree in Microbiology, Life Sciences, or a related scientific discipline

• Experience: Proven experience in a pharmaceutical or biopharmaceutical microbiology laboratory environment for about 10-12 years, with people management experience. Ability to work collaboratively in a fast-paced environment

• Technical Skills: Strong knowledge of microbiological testing methods, cGMP regulations (EU/US), and quality management systems

• Functional Skills: Experienced in Quality Management, Risk-Based Approach, Operational Excellence, and Safety Management

• Soft Skills: Strong leadership, communication, and team management capabilities; ability to drive continuous improvement and lead cross-functional collaboration

• Languages: Proficiency in English