Manager Quality Services - Third Party Audits, North ...

Job title: Manager Quality Services (Third Party Audits), North America, Business Operations Location: Framingham, MA, Swiftwater, PA, Ridgefield, NJ, Morristown, NJ % of Travel expected: Travel required 60% or based on business needs Job type: Permanent and Full time About the Job 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 across various domains including human vaccines, rare diseases, oncology, and consumer healthcare. More than 110,000 people in over 100 countries at Sanofi are dedicated to making a difference in patients' daily lives. 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, pioneering the application of Artificial Intelligence (AI) to enhance data standards and accelerate global health impact. 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, driving priority and transformative initiatives across M&S. Team members of Global M&S Services Hubs partner in carrying out tasks and fulfilling responsibilities to support established global quality processes. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We offer opportunities to explore, connect, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities Provide QA and Technical Support to Third Party Manufacturers (TPM) and Contract Manufacturer Organization (CMO), TPM/CMO Operations, Affiliates, and other Stakeholders. Ensure compliance with Corporate and Divisional QA policies, procedures, standards, and country-specific regulations. Identify and resolve Quality gaps and 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. Track market developments and regulatory changes. Follow up on CAPAs. Participate in audits and inspections, interfacing with specialists. Assess supplier's quality in relation to material compliance and regulatory CAPA before communicating to the request sites. Act as a local quality contact between Suppliers, Global Quality Suppliers & IA sites to facilitate follow-up of improvements and quality information exchange. Support audits led by other auditors when specific expertise is needed. Conduct on-site and remote audits of GxP and Health Regulated Third Party vendors to ensure compliance with regulations and company policies. Collaborate with stakeholders regionally for inspection preparedness. About you Experience: 3+ years of Compliance or Auditing experience. 5+ years of related experience in the pharmaceutical industry. Thorough knowledge of cGMPs and Code of Federal Regulations in drugs and biologics. Knowledgeable in Quality functions of the pharmaceutical industry. Experience in conducting on-site audits and facing regulatory/health authority inspections/audits. Thorough knowledge of CAPA systems is required. 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. Proficient in attention to detail and organizational skills. Ability to work in a team-oriented, flexible, and proactive manner. Strong analytical skills and ability to multitask in a stressful environment. Education: Bachelors/Master's in Life Sciences/Healthcare, or related technical field; Doctorates/Ph.D would be an added advantage. Languages: Excellent knowledge of 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 through a promotion or lateral move. Enjoy a thoughtful rewards package that recognizes your contribution. Take good care of yourself and your family with a wide range of health and wellbeing benefits. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to any characteristic protected by law. #J-18808-Ljbffr

Created: 2025-02-08