Expert I, Quality Operations (Modulus)

Expert I, Quality Operations (Modulus)

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 facilities to our global industrial footprint. These production units (Modulus) 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 Modulus Facilities will enable more responsive and flexible manufacturing across multiple vaccine and biological platforms including mRNA, while minimizing our impact on the environment. Our facility 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:

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

• Lead Quality Assurance oversight for all Quality Control (QC) testing operations.

• 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).

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

• Perform monitoring and trending of laboratory testing performance.

• Lead the site business process for Batch Disposition / Release.

• Lead the decision on batch disposition / release of raw material and manufactured batches implicated by quality event and investigation.

• Perform the timely disposition / release of manufactured batches and incoming materials.

• 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.

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

• Provide quality advice to GMP operational teams to ensure compliance, reliability, and efficiencies.

• Provide Quality Assurance oversight for Operations, including 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 in the biopharmaceutical industry.

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

• Knowledge of regulations and standards of the pharmaceutical industry.

• Strong interpersonal relationships to establish partnerships necessary for the development of an engrained Quality culture.

• Excellent verbal and written communication skills; effective communication and presentation skills across different levels of the organization.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability, or gender identity.