Quality Assurance Operational Support

Sanofi; Singapore; On-site; SGD 90,000 - 150,000; Full time

Job summary

Sanofi Singapore is seeking a Specialist II, Quality Operations to provide on-the-floor quality oversight and support for GMP manufacturing at Tuas site. You will partner with operations, QA, and technical teams to ensure compliance with global quality standards and regulatory expectations.

During PPQ and routine operations you will review documentation, contribute to CAPAs, deviations, and change controls, support digital manufacturing initiatives, and drive a culture of Quality across the

Qualifications

• Bachelor’s or Master’s Degree in Sciences, engineering or related technical field is required.
• Minimum of 4 years of relevant experience in pharmaceutical manufacturing, validation, engineering or quality roles.
• Strong knowledge of cGMP, data integrity, global quality policies and QA systems.
• Experience with regulatory inspections is a plus.

Responsibilities

• Provide direct GMP Quality oversight for all GMP operations (on-the-floor quality oversight, raw materials release, deviations, change controls and CAPAs).
• Review and approve engineering and operation documents; support IOQ activities for equipment and process-related documents.
• Support digital and automation infrastructure setup (DeltaV, MES, ERP modules) and ensure quality procedures are implemented for PPQ runs.
• Lead or participate in root cause investigations and escalate significant quality issues to management.
• Contribute to QA continuous improvement initiatives during routine operations and participate in regulatory inspections.

Skills

GMP operations

Quality oversight

CAPA & change controls

Document management system

Root cause investigations

On-the-floor QA support

Cross-functional collaboration

Quality culture champion

Education

Bachelor’s or Master’s Degree in Sciences, engineering or related technical field

Tools

SAP system

MES workflows

DeltaV

Electronic Batch Records (MES)

Job description

Job Title: Quality Assurance Operational Support Location: Tuas, Singapore

About the Job Mission Sanofi is preparing its future through an ambitious program named EVolutive Facility (EVF). The EVF Project is at the cornerstone of Sanofi Pasteur 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 vaccine business challenges. Digital will be one of the key topics to help EVF to reach its ambition. On top of it, Sanofi is also embarked with the ambition to leapfrog the competition through a digital acceleration program with the following vision: "Sanofi will fully integrate Digital capabilities & culture within its operations to boost business growth and profitability in 2026+". In this context, we are looking for Specialist II, Quality Operations for our new site based in Singapore.

Key Accountabilities The mission described below, must be exercised in compliance with health, safety and environment of the site rules. The Specialist II, Quality Operations will be responsible to partner with the GMP operations team to provide Quality oversight and advice for Quality on-the-floor and operations support to ensure the Tuas Singapore GMP Quality operations meets Sanofi global Quality standard requirements and fulfil the applicable regulatory expectations. The Specialist II, Quality Operations shall be experienced in solving complex problems, and strong understanding of cGMP operations and well-versed in multiple Quality systems (including exception management, change controls, deviations/CAPAs and document management system). The incumbent will partner closely with operational teams (e.g. manufacturing, facilities, Quality control and technical units) to ensure Quality, safety, reliability, efficiencies to support Tuas Singapore GMP manufacturing operations. During the Project Phase, the Specialist II, Quality Operations will participate in the following Engineering / Commissioning & Qualification activities: Engineering / Commissioning & Qualification activities (Line B): Review and approval of engineering documents related to GMP operations. Support and provide inputs to Installation, Operational Qualification (IOQ) activities for equipment used in GMP operations. Review and approval of operational, as well as process related documents (e.g. work instructions, SOPs, batch records). Support the digital and automation infrastructure setup including Delta V recipe, MES workflows, other process equipment related systems, ERP module setup, etc. Ensure that Quality related operational procedures and infrastructures are successfully implemented in preparation for Engineering runs and PPQ runs at the Tuas Singapore Site to support site operational readiness and success. Provide GMP Quality support during PPQ runs (Line A): Responsible to provide direct solid Quality advice to GMP operational teams to ensure compliance, reliability and efficiencies. Responsible to provide direct QA oversight for all GMP operations (including on-the-floor Quality oversight, raw materials and Drug Substance Intermediate release, deviations, change controls and CAPAs) at Tuas Singapore manufacturing facility. Represent Quality to triage, resolve on-the-floor operations issues, and participate in root cause investigations. Escalate significant Quality issues to Quality management in a timely manner. Champion Quality within the Operations team to establish an engrained Quality culture across the organization.

Working hours – Personnel shall be able to work office hours (weekdays) in Sanofi Site Office to support collaborations and meetings with stakeholders leading up to Engineering runs. Personnel shall be able to work 12 hours rotating shift (including day/night, and weekends) on site to support PPQ runs and Engineering runs, as required.

During Routine Operations, the Specialist II, Quality Operations shall: Be responsible to provide direct solid Quality advice to GMP operational teams to ensure compliance, reliability and efficiencies. Be accountable to ensure that Quality related operational procedures and infrastructures are successfully implemented to support EVF Singapore site operational and inspection readiness and success. Be responsible to provide direct QA oversight for all GMP operations (including on-the-floor Quality oversight, raw materials release, deviations, change controls and CAPAs) at Tuas Singapore manufacturing facility. Represent Quality to triage, resolve on-the-floor operations issues, and participate in root cause investigations. Escalate significant Quality issues to Quality management in a timely manner. Champion Quality within the Operations team to establish an engrained Quality culture across the organization. Lead and support the site driven QA continuous improvement initiatives/activities during the routine operational phase. Participate in regulatory inspections and interact directly with regulatory inspectors (as applicable). Lead and support QA Operations related trainings and coaching for the Quality organization. Contribute to reach the Tuas Singapore Quality manufacturing 4.0 ambition through a Quality plan. Working hours – Personnel must be able to work 12 hours rotating shift (including day/night, and weekends) on site to support production activities.

About You Education and experience Bachelor’s or Master’s Degree in Sciences, engineering or other related technical field. Minimum of 4 years of relevant experiences preferably in Manufacturing, Validation, Engineering, Quality in the pharmaceutical or biotechnology industry (preferably in vaccines and/or biologics). Key technical competencies and soft skills: Manufacturing 4.0 mindset (such as Agile methodology) Expert Knowledge of regulations and standards of the pharmaceutical industry, Global Quality policies and Data Integrity Requirements. Solid manufacturing process technical knowledge. Broad understanding of QA Operations (from an end-to-end perspective). Strong interpersonal skills to establish the partnerships necessary for the development of an engrained Quality culture and the correct execution in transverse. Ability to work independently and make quick, effective decisions under pressure. Discipline and assertiveness in the decision-making and execution of digital manufacturing strategy. Familiarity with electronic batch record (MES) and related review processes. Familiarity with batch release and disposition process, preferably using the SAP system. Proficient in QMS and Quality Risk Management Principles. Excellent verbal and written communication skills; effective communication and presentation skills across different levels of the organization, including senior management and execution levels. Experience in facility start-ups will be advantageous. Good understanding of risk-based decision framework. Familiar with Digital 4.0 concepts and potential applications in Quality.

Diversity und Inklusion sind in den Grundwerten von Sanofi verankert und spiegeln sich in unserer Arbeitsweise wider. Wir respektieren die Vielfalt unserer Belegschaft in Hinsicht auf ihre Herkunft, Erfahrungen und Lebensweisen. Wir erkennen die Bereicherung, die diese Vielfalt birgt, und fördern Inklusion sowie eine Arbeitsumgebung, in der diese Unterschiede sich weiter entwickeln können, zur Stärkung des Lebens unserer Mitarbeiter, Patienten und Kunden. Wir sind ein forschendes Biopharma-Unternehmen, das KI anwendet und sich dafür einsetzt, das Leben der Menschen zu verbessern und verantwortungsvoll zu wachsen. Unser Team wird von einem Ziel geleitet: Wir erforschen die Wunder der Wissenschaft, um das Leben der Menschen zu verbessern. Wir möchten eine gesündere, widerstandsfähigere Welt schaffen und das Unmögliche möglich machen, indem wir Medikamente und Impfstoffe für Millionen von Menschen weltweit entdecken, entwickeln und bereitstellen. Erfahren Sie mehr über uns auf www.sanofi.com oder schauen Sie sich unseren Film an: We are Sanofi Starte eine Karriere, die einen Unterschied macht. Neuerfindung liegt in unserer DNA. Sie hat unsere Entwicklung von einem kleinen französischen Unternehmen zu einem der weltweit führenden Biopharma-Unternehmen vorangetrieben. Ob es darum geht, KI zu nutzen, um die Zeiten der Arzneimittelforschung zu verkürzen, oder Vertrauen im Gesundheitswesen aufzubauen - du kannst unseren Teams dabei helfen, das Leben für Patienten, Partner und Gemeinschaften zu verbessern. Hier entwickelst du deine Karriere weiter. Wir öffnen dir die Tür, um neue Möglichkeiten zu entdecken, deine Grenzen zu erweitern und dich mit Menschen zu vernetzen, die von einem gemeinsamen Ziel angetrieben werden: Wir erforschen die Wunder der Wissenschaft, um das Leben der Menschen zu verbessern.