Sanofi
healthcare
QCManager,Microbiology
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“QC Manager, Microbiology at Sanofi. Skills: Microbiology, Quality Control, Process Management, Cross-functional Coordination, Vendor/Stakeholder Management, Operational Metrics, Resource Planning, Continuous Improvement. Lead and manage the day-to-day operations of the Microbiology team. ensuring performance and compliance with cGMP, HSE, and regulatory requirements”
What You'll Achieve.
performance and compliance with cGMP, HSE, and regulatory requirements; targets for quality, safety, and productivity are met; batch release; regulatory submissions
Industry & Context.
investigation and resolution of Out-of-Specification (OOS) results; investigation and resolution of deviations; investigation and resolution of CAPAs
What They're Looking For.
Must Have
Degree in Microbiology, Life Sciences, or a related scientific discipline, Proven experience in a pharmaceutical or biopharmaceutical microbiology laboratory environment for about 10-12 years, people management experience, Ability to work collaboratively in a fast-paced environment, knowledge of microbiological testing methods, knowledge of cGMP regulations (EU/US), knowledge of quality management systems, Experienced in Quality Management, Experienced in Risk-Based Approach, Experienced in Operational Excellence, Experienced in Safety Management, leadership, communication, team management ability, ability to drive continuous improvement, ability to lead cross-functional collaboration, Proficiency in English
What You'll Do.
Lead and manage the day-to-day operations of the Microbiology team
ensuring performance and compliance with cGMP
and regulatory requirements
Drive consistent planning
and improvement of microbiological testing activities
and development to a team of QC analysts
Ensure timely investigation and resolution of Out-of-Specification (OOS) results
Monitor and report on the team’s KPIs
ensuring targets for quality
and productivity are met
Ensure all laboratory equipment
and systems are qualified
and maintained in a state of compliance
Support internal and external audits and regulatory inspections
How You'll Work.
Team & Collaboration
Collaborate cross-functionally with Manufacturing, Quality Assurance, and Regulatory Affairs to support batch release and regulatory submissions; lead cross-functional collaboration
Communication Scope
communication
Process & Methodology
planning, execution
Full Job Description
**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, an
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