Skip to main content
Two women in white lab coats look at a computer screen together

Expert I, Quality Operations (EVF)

Singapore, Singapore Permanent Date posted 09/07/2024
Apply now

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 2025+”. In this context, we are looking for an Expert, Quality Operations for our new site based in Singapore.

Key Accountabilities

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 fulfils 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 fulfil 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 continue 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.

Education and experience

  • 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.

Key technical competencies and soft skills:

  • 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

  • Fluent in English speaking and writing; fluent in speaking and reading in another language common in the Asia Pacific region (e.g. Mandarin, Hindi, Tamil, Malay)

Apply Now
  • You have not viewed any jobs yet.

  • You have not saved any jobs yet.

Man at whiteboard pointing to presentation and looking at coworker

Developing
our talent

We believe better is out there – and that extends to how we support people. Our People Strategy prioritizes inclusivity, transparency, and efficiency in talent development. It’s allowed us to chart personalized plans to keep employees and managers on the same page when it comes to training and succession planning. From upskilling to mentorship, we prepare our teams with the resources they need to pursue progress.

Illustration of map pins on globe

Find out more about this location

Experience possibility

  • Your Saved Jobs

    Learn more
  • Cambridge Crossing

    We're bringing together 2,500 people from across our organization — R&D, Medical, Commercial and Global colleagues all working to realize the power of collaboration.

    Learn more
  • Innovation in Action

    Our flexible lab of the future will transform how we conduct research, while our innovation center will be fully integrated with existing R&D locations.

    Learn more
  • Sustainable and Green

    Our new facility was built to minimize the environmental impact — helping protect our planet and people. Using resources efficiently, we're providing greener, healthier workspaces.

    Learn more
  • Sanofi’s AI Centre of Excellence in Toronto

    The Centre is focused on using leading technologies to develop world-class data and artificial intelligence (AI) products to create value for the health sector.

    Learn more
  • Ama

    Ama puts her project management techniques and ServiceNow knowledge to use to help advance Sanofi’s Digital Data operating model. Learn how our team connects data and AI to do what’s never been done before.

    Learn more
  • Sanofi Canada's Philanthropic Efforts

    By chasing the miracles of science to improve people’s lives, we surprise ourselves with what we can achieve. Our team is humbled by the impact our efforts make.

    Learn more
  • Emmanuel

    Emmanuel, Head of the Sanofi Digital Accelerator, shares how his team builds digital solutions that enable patients to receive new treatments to help improve their lives.

    Learn more
  • Dimitrije

    Dimitrije shares insights into the work carried out by the AI Centre of Excellence in Toronto.

    Learn more
  • Ziv

    Read Ziv's first-hand account describing the reasons he chose to join Sanofi – and many of the reasons why he now chooses to stay.

    Learn more
  • When you grow, we all grow

    We strive to support your whole self with thoughtfully crafted rewards that benefit you physically, financially, mentally and socially. Whatever your role, you'll thrive in our inclusive teams.

    Learn more
  • Build a career with purpose

    Bring your passion to your role and impact millions of people around the world. You're in the driver's seat – just set your goals, and we'll provide the training and support that will get you there.

    Learn more
  • Bolder, better futures

    Change your life. And the lives of millions around the globe. How? By starting a career where you're supported to grow, while having a tangible impact and learning from the best.

    Learn more
  • Our locations

    We're in 60+ countries, all pulling together to define the future of healthcare. Wherever you work, you'll develop your career alongside experts, using technology to chase bigger breakthroughs.

    Learn more
  • Sanofi Stories

    At Sanofi every voice matters. Get to know the talented Sanofians shaping our future and pushing us toward our ambitious goals.

    Learn more
  • Sanofi at Cambridge Crossing

    Dubbed Sanofi at Cambridge Crossing, our new state-of-the-art facility will create an innovation hub promoting close collaboration and integration among business units. Join us and become part of a team dedicated to chasing the miracles of science that improve people’s lives.

    Learn more
  • Why Sanofi

    Get access to the tools, training, and support to reach your goals. By fulfilling your potential, you’ll help us achieve our aim of halving the time from discovery to therapy.

    Learn more
  • Our people & culture

    We're the first in Pharma to have a DE&I board. We also have Employee Resource Groups that create spaces for every Sanofian to be heard. Your voice matters – use it to shape our future.

    Learn more
  • Sanofi's Postdoctoral Program

    Designed for high-caliber Ph.D. graduates, Sanofi's Postdoctoral Program helps you advance your scientific career in a state-of-the-art environment.

    Learn more
  • Physician Careers at Sanofi

    At Sanofi, physicians like you have the opportunity to collaborate on new ideas and challenge established thinking. Learn about Physician careers here.

    Learn more
  • AI Centre of Excellence

    The AI Centre of Excellence at Sanofi is a unique data-driven team based in Downtown Toronto. We pride ourselves on being data-obsessed and highly focused on using state-of-the-art technologies to drive global impact.

    Learn more
Two women, seated in an office lobby, working on laptops and talking

What could we achieve together?

Want to join our Global Talent Community? Every Sanofian works on projects that truly make a difference to people’s lives.

What could you achieve? Sign up today and discover our latest opportunities as soon as they’re available.