_About the job_ **Main responsibilities** The Quality CSV D&Q Manager IFB (Computerised 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 Global Quality D&Q Lead. Commissioning & Qualification and Validation: • Responsible for the project CSV, Data Integrity, C&Q&V strategy execution, C&Q&V plans and System impact assessment. • 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. • Ensure Automation qualification and CS Validation in IFF compliant to Annex 1, Annex 15, GAMP 5 and applicable regulations • Responsible for the preparation and the execution of Automation DQ, SAT, FAT, IQ, OQ and nP-PQ protocols, final CQ reports and VMP • 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. **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)