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.

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.
 

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!