Manufacturing and Supply
Where the
miracles of
science are made
a reality for patients
M&S-IFB Commissioning & Qualification Lead-Beijing
At a glance
Our teams produce and deliver over 4 billion units of medicines and vaccines every year, ensuring every breakthrough gets to the people who need it most.
Our state-of-the-art facilities, AI-powered smart factories, and cutting-edge automation are redefining what’s possible: ensuring treatments reach patients faster, safer, and more sustainably than ever before. This is where your skills, ambition, and passion can shape the future of healthcare.
IFB Commissioning & Qualification Lead
About the job
Are you ready to jump into a mega project (> 1 B€ Capex program, thereof design/engineering budget
>>200 m€), and to bring in your experience & knowledge ? The race is on to design & build our new Insulin flex facility in Beijing addressing capacity increase demand.
Your skills could be critical in helping us to achieve our key project milestones. You will lead all Commissioning and Qualification activities from Basic Engineering until end of Qualification activities in accordance with EHS, Quality, Engineering, Business & Users requirements standard and expectations. Within the greenfield IFB (insulin Beijing Facility) project team, and part of our InsuLINK program for insulin drug substance facilities.
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.
Main responsibilities:
To lead the IFB C&Q team (system leaders, per workstream / group of systems).
To design C&Q detailed approach for IFB, based on endorsed InsuLINK strategy as per C&Q project plan, for all systems (GxP and non-GxP).
To coordinate the Sanofi C&Q work with the EPCMCQ engineering contractor for C&Q topic and all disciplines withing Sanofi IFB organization. And with InsuLINK C&Q Leader.
To ensure all C&Q documents are on time with Sanofi / EPCMCQ contractor, including FAT/SAT documents.
To author URS as per schedule.
To deliver C&Q activities and qualification report on time.
To lead and manage deviation process and ensure deviation are closed on time with all expected documents, with no impact on schedule L2.
To provide support to project change, engineering change and technical change assessment with regards to C&Q part.
To prepare transition after OQ/PQ with MSAT and Operations.
To collaborate to project meeting.
About you
Experience:
Several years of professional experience in managing teams (direct and indirect) in the pharmaceutical industry
Strong experience of pharmaceutical facility start-up and commissioning
Very good knowledge of commissioning and qualification in active pharmaceutical ingredient production environment, greenfield/brownfiled project and/or operational facility
Proven multi-year experience (>10 years) in the area of project and engineering management
Experience in working in a large, complex matrixes environment with global processes and governance structures.
Soft skills:
Very good communication and presentation skills
Systematic and structured work style
Result oriented and pragmatic
Technical skills:
Good knowledge of FDA/China and other regulatory requirements such as cGMP
Strong knowledge and experience in performing facility / equipment / utility commissioning and/or qualification, including automated and computerized system.
Good general technical knowledge, ability to interact with experts
Education:
Good general technical knowledge, ability to interact with experts
Languages:
Good general technical knowledge, ability to interact with experts
Why choose us?
Play an instrumental part in creating best practice within our manufacturing facility.
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact Pursue Progress. Discover Extraordinary
Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
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Why work with us
- We’re problem-solvers and pioneers. United by the belief that everyone deserves a healthier future. We create best-in-class vaccines that prevent disease and protect lives.
- Innovation drives us. From AI and mRNA to next-gen science, we push the boundaries to deliver first- and best-in-class vaccines for infectious diseases worldwide.
- Growth happens here. With bold investments in R&D and world-class facilities, Sanofians across the entire vaccine lifecycle are shaping the future of global health.
- We do what’s right. Sustainability and DE&I drive our positive global impact—because the diverse communities Sanofians represent are the patients we serve.
All-in on diversity
At Sanofi, diverse perspectives fuel the best solutions for patients. Hear from Monique Vessey, our Supply Chain Transformation Leader, on how her background shapes her approach to delivering life-changing medicines.
"Manufacturing and Supply is the bridge between the science that happens in research laboratories and the people and communities we serve."
Brendan O’Callaghan
Executive Vice President of Manufacturing and Supply
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