Quality Assurance Operational Support

Sanofi is preparing its future through an ambitious program named Modulus. The Modulus Project is at the cornerstone of Sanofi 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 Modulus 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 Quality Assurance Operational Support 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 Quality Assurance Operational Support 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 Quality Assurance Operational Support shall be experienced in solving problems, with a competent understanding of cGMP operations and well-versed in multiple Quality systems (including electronic batch record exception management, 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 Modulus Singapore GMP manufacturing operations.

1)     During the Project Phase, the Specialist I,Quality Operations will participate in the following:

• Engineering / Commissioning & Qualificationactivities
• Review and approval of engineering documents related to GMP operations.
• Review and approval of operational, as well as process related documents (e.g. work instructions, SOPs, batch records).
• 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.

2)     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 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.

3)     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.

Routine Operations, the Specialist I, 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 Modulus 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.

About You

• Bachelor’s or Master’s Degree in Sciences, engineering or other related technical field.
• Minimum of 2 to 5 years of relevant experiences preferably in Manufacturing, Validation, Engineering, Quality in the pharmaceutical or biotechnology industry (preferably in vaccines and/or biologics).
• Manufacturing 4.0 mindset (such as Agile methodology) and process technical knowledge.
• Basic 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.
• Familiarity with electronic batch record (MES)and related review processes.
• 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.