Quality Control PCU Manager

Sanofi; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

Sanofi Singapore is seeking a Quality Control Lab Lead to oversee day-to-day QC operations, ensuring testing is accurate, timely, and compliant with GMP and regulatory requirements.

You will coach and develop the QC team, maintain qualification and training matrices, support investigations and product release activities, and partner with MSAT, Manufacturing, and Engineering to drive quality and continuous improvement.

Qualifications

• Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, Life Sciences, Technology.
• Minimum 3 years of relevant experience in a Quality Control laboratory within the pharmaceutical/biotech industry, including leadership experience.
• Good working knowledge of GMP, laboratory quality systems, and applicable regulatory requirements.
• Experience supporting pharmaceutical/biotechnology manufacturing operations, product release activities, investigations, CAPAs, and regulatory inspections is advantageous.

Responsibilities

• Oversee day-to-day QC laboratory operations.
• Ensure GMP compliance and adherence to quality standards.
• Lead analytical methods validation and transfer activities.
• Coach and develop laboratory staff.
• Train personnel and maintain qualification/training matrix.
• Conduct shopfloor walkthroughs to identify improvement opportunities.
• Review test results and support batch release activities.
• Maintain laboratory equipment and calibration/qualification.
• Lead investigations, CAPAs, change controls within QC scope.
• Support regulatory inspections and audits with documentation.

Skills

Analytical thinking

Leadership

GMP knowledge

Regulatory knowledge

Data interpretation

Education

Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, Life Sciences, Technology

Tools

LIMS

Job description

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.