Quality Control PCU Manager

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About the role

About the Job Sanofi is preparing its future through an ambitious program named Modulus. The Singapore Modulus site is at the cornerstone of Sanofi Manufacturing & Supply (M&S) strategy as it aims at creating a new manufacturing concept consisting of a new generation of evolutive multi-product facilities, modular, adaptable, and agile, leveraging new disruptive technologies to better address business challenges. Key Accountabilities • Oversee the day-to-day operations of the Quality Control (QC) laboratory, ensuring testing activities are completed accurately and in accordance with committed schedules and priorities. • Ensure laboratory operations remain compliant with Good Manufacturing Practices (GMP) , internal quality standards, applicable procedures, and regulatory requirements. • Ensure validated analytical methods are used within the laboratory’s scope and support the execution of analytical method validation and transfer protocols as the receiving unit. • Lead, manage, coach, and develop laboratory staff, ensuring adherence to laboratory best practices, quality standards, and safety requirements. • Ensure laboratory personnel are appropriately trained and qualified to perform assigned testing activities, maintaining an up-to-date laboratory qualification and training matrix. • Conduct routine laboratory shopfloor walkthroughs to identify potential quality, safety, operational, and continuous improvement opportunities. • Ensure accurate and timely testing of samples received within the laboratory’s scope. • Review analytical test results against approved specifications and assess analytical batch records to support product batch release activities on behalf of the Head of Quality Control. • Ensure laboratory equipment and instruments are appropriately maintained, qualified, and calibrated in accordance with established plans to support reliable and accurate testing. • Ensure timely follow-up and closure of investigations, change controls, deviations, and Corrective and Preventive Actions (CAPAs) within the laboratory’s scope. • Lead and support investigations into QC events, issues, discrepancies, and atypical results, ensuring appropriate root-cause analysis and timely implementation of remediation and CAPA actions. • Support regulatory inspections and internal/external audits by providing documentation, information, and responses related to the laboratory’s scope. • Maintain laboratory facilities, equipment, and instruments in an appropriate state of quality, compliance, and safety to ensure continued operational readiness. • Drive a culture of quality, compliance, safety, operational excellence, and continuous improvement across laboratory operations. Education & Experience • Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, Life Sciences, Technology , or a related discipline. • Minimum 3 years of relevant experience in a Quality Control laboratory within the pharmaceutical or biotechnology industry, including experience managing or leading a team. • Good working knowledge of Good Manufacturing Practices (GMP) , laboratory quality systems, and applicable regulatory requirements. • Experience supporting pharmaceutical or biotechnology manufacturing operations, product release activities, investigations, CAPAs, and regulatory inspections would be advantageous. Key Technical Competencies & Soft Skills • Strong analytical and critical-thinking skills, with the ability to interpret complex laboratory data and test results, identify trends, and make sound quality-related decisions. • Demonstrated leadership and people-management capabilities, with the ability to coach, motivate, and develop laboratory teams while maintaining high standards of performance and complian

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