Quality Control PCU Manager

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 compliance.
• Strong attention to detail and commitment to data accuracy, documentation quality, and regulatory compliance.
• Effective problem-solving skills, with the ability to investigate quality issues, identify root causes, and implement sustainable corrective and preventive actions.
• Strong organisational and prioritisation skills, with the ability to manage multiple laboratory activities and deliver against operational timelines.
• Effective communication and stakeholder-management skills, with the ability to collaborate across Quality, Manufacturing, MSAT, Engineering, and other cross-functional teams.
• Continuous improvement mindset with a proactive approach to enhancing laboratory efficiency, quality, safety, and ways of working.