**Job title** : Head of IFB (Insulin Facility Beijing) Operations + Location : China **Background** Sanofi has decided to invest into a new large state-of-the art facility for Insulin Drug Substance in Beijing, China. 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. One important role of this program organization is the IFB (Insulin Facility Beijing) Operations Head reporting to the Global Operations Head of the new insulin facilities program. **_About the Role_** The IFB Operations Project Head will play a crucial role in partnering engineering during the project and in developing, establishing and managing Sanofi's new insulin manufacturing facility in China. This position requires a strategic thinker with strong project and operational expertise in biologics manufacturing, particularly in the Chinese market. **Key addition:** This position will be a legal representative for the new site and will be a critical interface to external regulatory and government bodies. The IFB Operations Head will represent both the project and Sanofi in official capacities. This role involves building and maintaining relationships with Chinese authorities, effectively communicating project progress, ensuring compliance with local regulations, and advocating for the company's interests in the Chinese pharmaceutical landscape. **Key Responsibilities** **1.** **China-Specific Operational Strategy** + Develop and implement a future-oriented, highly efficient operational concept + Design an organizational structure that aligns with Chinese business practices and regulatory requirements. + Implement training concepts to local Chinese operational workforce, considering cultural nuances and educational backgrounds. **2.** **Engineering Partnership** + Partner closely with engineering functions to ensure operational expertise is integrated throughout the program. + Collaborate with engineering teams to align design and implementation of facilities and equipment with operational needs and future requirements. + Provide operational insights and requirements to inform engineering decisions, ensuring that all engineering activities are well-suited to long-term operational needs. 3. **Operational Leadership and Innovation** + Lead and oversee all operational activities within the IFB facility, driving a culture of continuous innovation and technological advancement. + Develop and implement pioneering operational concepts specific to the IFB **4.** **Project Leadership** + Lead all operational activities within the program for the China site, from inception to commercial readiness. + Establish and deliver user requirements for insulin products specific to the Chinese market and manufacturing unit. + Ensure seamless implementation of biologics manufacturing processes, cGMP requirements, and quality standards that meet both international and Chinese regulatory expectations. **5.** **Digitalization** + Implement sustainable concepts based on global digital directions + Spearhead the design of operational processes based on fully digitalized systems, aligning with China's rapid technological advancements and digital transformation initiatives. **6.** **Regulatory Compliance and Stakeholder Management** + Lead and contribute to authority interactions and submissions related to the China site + Collaborate with local stakeholders + Ensure compliance to FDA and EMEA regulations in addition to China regulations _Qualifications_ + Master's degree or PhD in Chemical Engineering, Biotechnology, Bioengineering, or related field from a reputable institution (Chinese or international). + 10+ years of experience in Biologics DS manufacturing, with significant exposure to the Chinese pharmaceutical industry. + Proven experience in cGMP operations & project execution within the Chinese regulatory framework. + In-depth knowledge of Chinese cGMP and regulatory requirements for biologics manufacturing. + Technical expertise in biotech upstream and/or downstream manufacturing, with an understanding of how these processes may need to be adapted for the Chinese market. + Experience with automation, PAT technology, and online analytics, particularly in the context of Chinese manufacturing practices. + Demonstrated ability to build and lead high-performing teams in a Chinese cultural context. + Strong skills in organization design, change management, talent management, and strategic workforce planning, with an emphasis on Chinese labor practices and cultural norms. + Excellent leadership, communication, and teamwork skills, with the ability to navigate complex cross-cultural environments. + Extensive intercultural experience, especially within China and between China and global teams. + Fluency in English and Mandarin Chinese (both written and spoken) is required. _Further Preferred Qualifications_ + Experience working with Chinese government bodies and regulatory agencies in the pharmaceutical sector. + Knowledge of local Chinese business practices, etiquette, and networking (guanxi). + Familiarity with Chinese labor laws and HR practices in the pharmaceutical industry. **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) ! 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)