Manager, Quality Operations
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 2025+”. In this context, we are looking for a Manager, Quality Operations for our new site based in Singapore.
The mission described below, must be exercised in compliance with health, safety and environment of the site rules.
The Manager, Quality Operations will be responsible to partner with GMP operations team to provide Quality oversight and advice for Quality on-the-floor and operations support to ensure the EVF Singapore GMP Quality operations meets Sanofi global quality standard requirements and fulfil the applicable regulatory expectations. The Manager, Quality Operations shall be experienced in solving complex problems, possess 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 EVF Singapore GMP manufacturing operations.
During the Project Phase, the Specialist II, Quality Operations will lead a team of Quality Professionals and participate in the following Engineering / Commissioning & Qualification activities:
Engineering / Commissioning & Qualification activities:
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 EVF Singapore Site to support site operational readiness and success.
Provide GMP Quality support during PPQ runs:
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 release, deviations, change controls and CAPAs) at EVF 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 shift (including weekends) on site to support PPQ runs and Engineering runs, as required.
Work from Home (hybrid) arrangements are subjected to discussion with Function Manager during the Project Phase.
During Routine Operations, the Manager, Quality Operations shall:
Lead a team of quality professionals with the goal to establish an engrained quality culture across the organization.
Provide direct solid quality advice to GMP operational teams to ensure compliance, reliability and efficiencies.
Provide direct QA oversight for all GMP operations (including on-the-floor quality oversight, raw materials release, deviations, change controls and CAPAs) at EVF Singapore manufacturing facility.
Ensure that all quality related operational procedures, infrastructures are successfully implemented to support EVF Singapore site operational and inspection readiness and success.
Be the lead quality representative to triage, resolve on-the-floor operations issues, and participate in root cause investigations.
Lead and support the site driven QA continuous improvement initiatives/activities during the routine operational phase.
Lead and participate in regulatory inspections and interact directly with regulatory inspectors (as applicable).
Escalate significant quality issues to Quality management in a timely manner.
Lead and support QA Operations related trainings and coaching for the Quality organization.
Contribute to reach the EVF quality manufacturing 4.0 ambition through a Quality plan.
Working hours –
Personnel must be able to work 12 hours shift (including weekends) on site to support production activities.
Education and experience
Bachelor’s or Master’s Degree in Sciences, engineering or other related technical field.
Minimum of 8 years of relevant experiences preferably in Manufacturing, Validation, Engineering, Quality in the pharmaceutical or biotechnology industry (preferably in vaccines and/or biologics).
Minimum 2 years of managerial experience in the pharmaceutical or biotechnology industry.
Key technical competencies and soft skills:
Manufacturing 4.0 mindset (such as Agile methodology)
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 perspectives).
Strong interpersonal relationships in order to establish the partnerships necessary for the development of an engrained Quality culture and the correct execution in transverse.
Discipline and assertiveness in the decision-making and execution of digital manufacturing strategy and execution.
Familiarity with electronic batch record (MES) and lot disposition process using 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.
Experienced 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
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.