Quality Control PCU Manager

Biopharma Careers; Singapore; On-site; SGD 120,000 - 190,000; Full time

Job summary

Sanofi is advancing its Modulus program with a Singapore site focused on modern, evolutive multi-product facilities and disruptive technologies to enhance manufacturing excellence.

Leading the QC laboratory, you will oversee daily testing operations, ensure GMP compliance, mentor staff, and support method validation, transfers, and product release activities while maintaining readiness for audits and regulatory inspections.

Qualifications

• Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, Life Sciences, Technology, or a related discipline.

Responsibilities

• Oversee day-to-day QC laboratory operations, ensuring testing aligns with schedules and priorities.
• Ensure GMP compliance, quality standards, procedures, and regulatory requirements.
• Support analytical method validation and transfer within the lab scope.
• Lead, coach and develop laboratory staff; maintain qualification and training matrix.
• Review test results against specifications and support batch release activities.
• Maintain and calibrate laboratory equipment; support investigations, CAPAs, and deviations.
• Support regulatory inspections and audits with documentation and responses.

Skills

Leadership

GMP knowledge

Analytical thinking

Regulatory understanding

Quality systems

Stakeholder management

Education

Bachelor’s or Master’s degree in Pharmacy or related

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.

Pursue progress , discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !