Job title: CC & MQC Lead IFB

Location: Beijing Site

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 CC & MQC Project Lead IFB (Contamination Control and Microbiological Control, Insulin facility Beijing) is responsible for ensuring that all aspects of Contamination Control and microbiological Quality Control across the project during conceptional, basic and detailed design, construction C&Q, PQ, Validation and future site organizations until final approval. The position will hold overall responsibility for the successful delivery of all Contamination Control and microbiological Quality Control of the project in China, including regulatory approval and transition to commercial production.

As an integral part of the project quality team, this position has overall accountability for the functions of Contamination Control and microbiological Quality Control in China. Assurance of a sustainable compliance of the project and future site with legal and quality requirements by continuous consideration of further and new developments in regulatory requirements. Assurance of the most effective use of the available resources for contamination control and microbiological quality control based on SMS 2.0 principles, leading/participating in project workstreams, ensuring proper execution of C&Q&V strategies as well as providing support and guidance for contamination control and microbiological quality control 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:

• Is responsible of the delivery of all the IFB contamination control and microbiological quality control aspects of the project, within the allocated budget, project schedule and the expected objectives.

• Builds and manages the IFB contamination control and microbiological quality control project team consisting of internal and external experts.

• Ensures the project is performed according to the Sanofi Standards and Good Practices.

• Ensures regular reporting to the Global Quality Program Lead.

• Ensures strategic workforce planning of the CC & MQC organization during both project and routine manufacturing modes.

• Develops strategic and operational synergies with the existing Beijing DP site.

• Works with existing Frankfurt organization and global SME network.

Commissioning & Qualification and Validation:

• Ensures development, implementation and assurance of CC & MQC in IFB.

• Defines and oversees the project C&Q&V strategy, C&Q&V plans and System impact assessment.

• Ensures the preparation and the execution of DQ, SAT, FAT, IQ, OQ and nP-PQ protocols, final CQ reports and VMP.

• Interacts with the IFF (Insulin Frankfurt Facility) to keep benchmark and best practices cross-fertilization.

• Responsible for the consistency of the turnover package to system owners.

Project Control, Cost & Schedule:

• Responsible for the IFB CC & MQC budget and schedule.

• Responsible for the regular collection of actual contamination control and microbiological quality control cost and progress.

• Responsible for the project compliance with Sanofi Cost & Schedule Policies and Standard.

• Contributing to decision making process regarding Cost & Schedule optimization.

About you

Experience

8 years industry experience, preferably within the biopharma and/or Microbiological Quality Control at an industrial (Pharma or food is preferred) site.Minimum of +5yrs in Leadership position with a proven track record of delivery and compliance.I'll help you integrate the GxP and health-related regulations text into the existing content. LetKnowledge & experience in Commissioning & Qualification, Process Validation Lifecycle, Quality by Design principles, transversal validations activities, as well as Pharmaceutical Manufacturing with production processing including automation, GxP and health-related regulations including Annex 1 knowledge in production and development of active substances and drug product (e.g. Steriles, Vaccines and Biotechnology), 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 Biology/Microbiology/Pharmacy or Equivalent.Ideally MSc or PhD level qualification in Science.

Languages

Excellent communication skills (written and oral) in EnglishChinese (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!

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But 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. So, let’s be those people.

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.

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