Quality Control PCU Manager

Sanofi India; Singapore; On-site; SGD 100,000 - 140,000; Full time

Job summary

Sanofi India is seeking a qualified leader to oversee the QC laboratory operations within a GMP-driven environment in Singapore. You will manage day-to-day testing, ensure compliance with quality and regulatory standards, and support method validation and product release activities.

You will lead, coach, and develop the laboratory team, maintain qualification and training matrices, and drive continuous improvement while collaborating with cross-functional teams to ensure timely testing and

Qualifications

• Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, Life Sciences, Technology, or related discipline.
• Minimum 3 years in a Quality Control laboratory within pharma/biotech, including leading a team.
• Good working knowledge of GMP, quality systems, and regulatory requirements.
• Experience supporting pharma/biotech manufacturing operations, product release, investigations, CAPAs, and regulatory inspections would be advantageous.

Responsibilities

• Oversee day-to-day QC laboratory operations and ensure testing aligns with schedules and priorities.
• Ensure GMP compliance and adherence to internal quality standards and regulatory requirements.
• Validate analytical methods and support method validation and transfer protocols.
• Lead and develop laboratory staff, maintaining training matrices and best practices.
• Monitor testing accuracy, review results against specs, and support batch release activities.
• Maintain equipment qualification and calibration plans for reliable testing outcomes.
• Drive investigations, CAPA actions, and timely closure of deviations.
• Support regulatory inspections and audits with documentation and responses.
• Foster a culture of quality, safety, and continuous improvement in lab operations.

Skills

Leadership

GMP knowledge

Analytical thinking

Data accuracy

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.

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.