Expert I, Quality Operations (EVF)

Expert I, Quality Operations (EVF)

Job title: Expert I, Quality Operations

• Location: Singapore

• Hiring Manager: Senior Manager, QA Operations

About the job:

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Sanofi has added two new Evolutive Facilities to our global industrial footprint. These production units (EVF) represent the future of manufacturing. They allow us to increase our capacities while making production more flexible and respectful of the environment.

Fully digitalized, our Evolutive Facilities (EVF) will enable more responsive and flexible manufacturing across multiple vaccine and biological platforms including mRNA, while minimizing our impact on the environment. Our EVFs will help improve people’s lives by giving them faster access to more treatments.

Main responsibilities

The Quality Operations sub-team is under the remit of the Site Quality Department and is responsible for providing Quality oversight and advice to the site GMP Operations team (e.g. manufacturing, facilities, quality control and technical units) to ensure that Site Operations meets Sanofi global quality standard requirements and fulfills the applicable regulatory expectations. The sub-team will also partner closely with the site GMP Operations team in solving complex problems to ensure quality, safety, reliability, efficiencies as well as manage multiple quality systems including, but not limited to change controls, deviations, laboratory investigations and CAPAs.

The Expert I, Quality Operations will primarily focus on providing Quality Assurance oversight to all Quality Control (QC) and testing topics at Sanofi to meet Sanofi global quality standard requirements and fulfill the applicable regulatory expectations. Additionally, he/she will also lead the site process for Change Control and Batch Disposition / Release.

The Expert I, 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, laboratory investigations, document management system, batch disposition and analytical method and equipment qualification).

The Expert I, Quality Operations shall:

• Provide direct solid quality advice to GMP operational teams, with a focus on

• Lead Quality Assurance oversight for all Quality Control (QC) testing operations. A compliant, reliable and efficient QC operations is critical to ensuring the site continues to maintain our licence to operate.

• Provide solid Quality Assurance advice to QC based on extensive experience with QC testing methods, QC operations (e.g. sampling, data integrity, analytical methods, stability and testing equipment controls and qualification).

• Independently review and approve QC operational and investigational documents or records (e.g. SOPs, Work Instructions, sampling plans, deviations, CAPAs, laboratory investigations and change controls), ensuring these meet the prevailing regulatory requirements and industry good practices.

• Represent Quality Assurance to triage, resolve on-the-floor QC testing issues and participate in root cause investigations.

• Represent the site as the Operations Business Quality Representative for Quality Control systems and processes.

• Perform monitoring and trending of laboratory testing performance through activities such as Continued Performance Verification of Analytical Procedures and routine walkdowns.

• Lead the site business process for Batch Disposition / Release of both manufactured batches (e.g. bulk drug substance, intermediates) and incoming materials. Implement and maintain the site batch disposition / release program, and the continuous improvement of the program.

• Lead the decision on batch disposition / release of raw material and manufactured batches implicated by quality event and investigation, ensuring the batch disposition / release decision are scientifically sound and can stand up to scrutiny.

• Perform the timely disposition / release of manufactured batches (e.g. bulk drug substance, intermediates) and incoming materials, ensuring all quality aspects of the batches are reviewed and assessed prior to releasing the batches for use or shipment to the secondary customers.

• Be the Subject Matter Expert on Batch Disposition / Release to handle all queries during regulatory and customer audits/inspections.

• Lead the site Change Control process, ensuring the site functions adhere to the rigour of the process and all changes are properly assessed and managed.

• Chair the site Change Review Board to ensure proper management and oversight of changes by senior site stakeholders.

• Be the Subject Matter Expert on the change control management process to handle all queries during regulatory and customer audits/inspections.

• Provide quality advice to GMP operational teams (e.g. manufacturing, facilities and technical units) as a cover for the other Quality Operations team, to ensure compliance, reliability and efficiencies.

• Provide Quality Assurance oversight for Operations, including but not limited to reviewing and approving Operations relevant documents and records.

Working hours –

• Personnel must be able to work office hours (weekdays) on site to support operational activities.

About You

• Bachelor’s or Master’s Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology or related life Sciences or Technology with at least 8-10 years of relevant experience working in the biopharmaceutical industry in areas such as Manufacturing, Validation, Engineering, Quality Operations, Quality Control and at least 2 years experience in the area of Quality Control.

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

• Sound practitioner of Manufacturing 4.0 mindset (or equivalent Lean or Agile methodology)

• Knowledge of regulations and standards of the pharmaceutical industry, Global Quality policies and Data Integrity Requirements.

• Solid process technical knowledge in the areas of Quality Control and Manufacturing.

• Broad understanding of QA Operations (from an end-to-end perspective).

• 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. Good understanding of risk-based decision framework.

• Experience in facility start-ups will be advantageous.

• Familiar with Digital 4.0 concepts and potential applications in Quality.

• Sound knowledge of regulations and standards of the pharmaceutical industry, Global Quality policies and data integrity requirements governing laboratory operations.

• Strong knowledge of the quality systems, analytical techniques, analytical instrumentation and associated technologies.

• Excellent verbal and written communication skills; effective communication and presentation skills across different levels of the organization, including senior management and execution levels.

• Good understanding of risk-based decision framework.