
Manufacturing and Supply
Where the
miracles of
science are made
a reality for patients
M&S - Quality CSV Design and Qualification Manager- IFB- BJ
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.
About the job
Sanofi has decided to invest into a new large state-of-the art facility for Insulin Drug Substance in Beijing, China. For this green field operation, we’re enhancing our legacy of excellence and build on decades of expertise on the whole value chain of insulin manufacturing. The new facility will be designed as a fully automated, green, modern, and state-of-the-art biologics facility. A large global and highly cross-functional program organization will be established to lead and execute the program until commercial routine manufacturing.
Meet Katrin, our Global Program Leader, and discover how we’re transforming insulin production. Watch now!
Main responsibilities
The Quality CSV D&Q Manager IFB (Computerized System Validation, Design & Qualification, Insulin facility Beijing) is responsible for ensuring that all aspects of CSV, Data Integrity and validation activities for the project, including design, qualification of facilities, critical utilities, equipment, and computerized systems, automation and digitalization, are executed on time and in accordance with the C&Q / Validation Master Plan, local and global requirements, and applicable regulations.
As an integral part of the project quality team, this position has overall responsibility for participating in project workstreams, ensuring proper execution of design/qualification/validation strategies as well as providing support and guidance for quality processes and procedures.
This role is expected to work independently and with a level of autonomy and authority in decision-making to ensure on-going compliance against approved documents and current Good Manufacturing Practices across the project during conceptional, basic and detailed design, construction C&Q, PQ, Validation and future site organizations until final approval.
Management:
• Ensures the project is performed according to the Sanofi Standards and Good Practices.
• Ensures regular reporting to the Quality Design &Qualification Head IFB.
Commissioning & Qualification and Validation:
• Responsible to drive Data Integrity Strategy in IFB in collaboration with Automation, MSAT, Operations and CQ team, with focus on data integrity in GxP alarms, electronic Batch release, Quality data processing in IFB.
• Oversee as Quality the Strategy and Execution of Automation and computerized Equipment Design, Automation C&Q and integration in C&Q&V, code testing, integration and documentation by external vendors.
• Responsible for the oversight of the preparation and the execution of DQ, SAT, FAT, IQ, OQ and nP-PQ protocols, final CQ reports and VMP
• Ensure Automation qualification and CS Validation in IFB compliant to local regulations, Annex 1, Annex 15, GAMP 5 and applicable regulations
• Interacts with IFF to keep benchmark and best practices cross-fertilization.
• Responsible for the consistency of the turnover package to system owners.
Project Control, Cost & Schedule:
• Supporting the regular collection of actual quality Data Integrity and C&Q project cost and progress.
• Ensures the project compliance with Sanofi Cost & Schedule Policies and Standard.
About you
Experience
5-8 years of industry experience in biopharma or related regulated industry, specifically in computerized system validation, commissioning, qualification/ validation.
In-depth knowledge of regulatory requirements around data integrity, validation, automation, and digitalization. Experience with quality data integrity, validation execution strategy, and GMP compliance.
Expertise in quality systems, risk management, and continuous improvement methodologies.
Ability to navigate complex projects and implement new technologies and digitalization initiatives.
Knowledge & experience in Commissioning & Qualification, Process Validation Lifecycle, Quality by Design principles, transversal validations activities, as well as Pharmaceutical Manufacturing with production processing including automation, scientific writing, effective oral and written communication skills, and innovative thinking. Familiarity with strategic planning, balanced judgment and risk analysis.
Experience working on large capex projects in Asia (China, Singapore, etc) is a strong asset.
Soft skills
Collaborate effectively with peers, stakeholders, partners across the organization to positively impact business results.
Act for innovation, initiating new and improved ways of working.
Develop teams in anticipation of future business needs.
LEAN oriented, problem solving & new way of working.
Open minded and curios to learn new tools.
Technical skills
In-depth knowledge of the biologic product license application process, and the associated regulatory requirements.
Know-how in Quality systems, Quality Risk Management, Continuous improvement management, GxP and health regulated regulations, International and FDA exposure, KNEAT solution is a plus.
Education
Degree in Engineering/Science/Pharmacy or equivalent.
Ideally MSc or PhD level qualification in science.
Languages
Excellent communication skills (written and oral) in English
Chinese (Mandarin) is a strong asset.
Why choose us?
- 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.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
PursueProgress. 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.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
nullPursue Progress. Discover Extraordinary.
Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and 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, gender identity, protected veteran status or other characteristics protected by law.
Watch 'One day at Sanofi' and check out our Diversity Equity and Inclusion initiatives at sanofi.com
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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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