Time left to apply: End Date: October 31, 2024 (11 days left to apply) Job Requisition ID: R2747700 About the Job The purpose of this role is to: Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes, and cardiovascular solutions and consumer healthcare. More than 110,000 people in over 100 countries at Sanofi are dedicated to making a difference in patients' daily lives, wherever they live, and enabling them to enjoy a healthier life. As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with a strong commitment to developing advanced data standards to increase reusability & interoperability and thus accelerate impact on global health. The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams in partnership with Business and Digital, and driving priority and transformative initiatives across M&S. The team members of Global M&S Services Hubs will act as partners to the M&S organization in carrying out tasks and fulfilling responsibilities to support identified and established global quality processes from the hubs. Main Responsibilities Provide QA and Technical Support to Third Party Manufacturers (TPM) and Contract Manufacturer Organizations (CMO), TPM/CMO Operations, Affiliates, and other Stakeholders. Responsible for compliance with Corporate and Divisional QA policies, procedures, standards, and specifications as well as country-specific regulations depending on the TPM location and markets. Ensure compliance with Corporate and Divisional QA requirements and identify and/or resolve Quality gaps and/or issues relating to product design, manufacturing quality programs, and product start-ups at TPMs. Responsible for overall quality and safety of products manufactured at those facilities. Utilize understanding of QA systems and problem-solving tools to provide alternative solutions to quality issues. Manage supplier audits, ensuring cGMP and SOP alignment. Follow up on CAPAs. Participate in audits, inspections, and interface with specialists. Provide an assessment of supplier's quality in place with regards to material compliance, as well as regulatory of CAPA before communicating it to the request sites. Act as a local quality contact between the Suppliers, Global Quality Suppliers & IA sites to facilitate follow-up of improvements and exchange of quality information. Support audits led by other auditors when specific expertise is needed (e.g., for cause audit with user sites representatives, highly sophisticated topic). Conduct on-site and remote audits of GxP and Health Regulated Third Party vendors to ensure compliance with regulations and company policies. About You Experience 4+ years of experience in Third Audit Parties. 7-10 years of related experience in the pharmaceutical industry. Thorough knowledge of cGMPs, Code of Federal Regulations in drugs and biologics. Knowledgeable in Quality functions of the pharmaceutical industry. Experience in conducting on-site audits, inspections, and facing regulatory/health authority inspections/audits. Thorough knowledge of CAPA systems is required and experience is desirable. Thorough knowledge of and experience in the application of GMP requirements. Experience managing third-party manufacturers and/or contract manufacturer organizations is preferred. Experience working on manufacturing sites is an added advantage. Required Skills Excellent problem-solving and decision-making skills are critical to this position. The successful candidate must be able to demonstrate their risk-based decision-making ability. Proficient in problem-solving, attention to detail, and good organizational skills. Work in a team-oriented, flexible, and proactive manner. Analytical skills and ability to multitask in a stressful environment. Education Master's or Ph.D. in Life Sciences/Healthcare, or related technical field. Languages: Excellent knowledge of the English language (spoken and written). 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. 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. 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, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability, or gender identity. 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 by visiting or via our movie We are Sanofi. Why Sanofi 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. #J-18808-Ljbffr