**To ensure a rapid processing of your application, please apply only via the “Apply” button. Please include a letter of motivation and a current resume with your application.** **_About the job_** Be part of a once-in-a-generation project that’s shaping the future of insulin. As part of a cross-functional program team, you’ll help bring a new facility to life – from early design and construction through to readiness for commercial manufacturing. Your work will help turn the miracles of science into reality for millions living with diabetes. **Position Overview** Being the Interface to the MQC-Lab of the Future project, the Microbiology Quality Control Manager IFF provides leadership for Quality Control lab during all project phases and future site organizations until final approval. Endorse micro quality control lab decisions at project level, participate in the development of the project and future sites strategy: Ensures the quality control of Sanofi products in a complex environment and within the strongly regulated area of the production of active substances with the chosen quality strategy, the applied processes and technologies as well as the appointed personnel. Assurance of sustainable compliance of the project 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 quality control. **Main responsibilities:** + Lead the Microbiology Quality Control lab team by providing appropriate training, mentoring, review and development to ensure retention of talented people and robust succession planning across key positions. + Provide leadership, strategic guidance and recommend policies, procedures, and activities ensuring robust quality control and product protections are in place. + Responsible for the delivery of micro quality control lab aspects of the project, within the allocated budget, schedule and the expected objectives, performances, HSE, Quality + Manage micro quality control lab team consisting of internal and external experts in close cooperation with the Frankfurt BioCampus (FBC) + Ensure the project is performed according to the Sanofi Standard and Good Practices + Guarantee regular reporting to the Global Contamination Control and Micro Qaulity Control Project Lead Insulink + Maintain development and validation of micro methods as well as transfer of methods to IFB in close cooperation with the FBC + Ensure execution of project C&Q&V strategy, C&Q&V plans and System impact assessment + Oversee lab readiness to perform the needed activities in the project phases while Interacting with the 2 InsuLINK sites to keep benchmark and best practices. **_About you_** + **Education/Experience** : MSc or PhD d _egree or equivalent in natural sciences, ideally Microbiology/Pharmacy;_ experience in Leadership positions with a proven track record of delivery and compliance; _significant industry experience,_ preferably within the Mirobiology Quality Control or Sterility Assurance position at an industrial _site;_ In-depth knowledge of the biologic product license application process, and the associated regulatory requirements including Annex 1 knowledge in production and development of active substances and drug product (e.g. Steriles, Vaccines and Biotechnology) + **Soft and technical skills** : Leadership and assertiveness skills; knowledge of Quality systems, Quality Risk Management, Continuous improvement management, GxP and health regulated regulations, International and FDA exposure + **Languages** : proficiency in German and English required **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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/) Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)