Global M&S Services, Manager Quality Services - Third Party Audits, Budapest Hub

Job title: Global M&S Services, Manager Quality Services - Third Party Audits, Budapest Hub Location: Budapest Job type: permanent, full time Travel required as per job demands Hybrid working   About the job We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Join our Global Manufacturing and Supply Services Team as Manager Quality Services – Third Party Audits and you can help make it happen. Our mission is to deliver and support Global M&S teams in partnership with Business and Digital, and drive priority and transformative initiatives across the organisation. Be part of something exceptional. Our Budapest Hub has been recognized for workplace excellence, innovation, and our commitment to putting people first. See the full list of our awards at the end of this posting. Main responsibilities: Provide QA and Technical Support to Third Party Manufacturers (TPM) and Contract Manufacturer Organization (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 to 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.  Track market developments, regulatory changes.  Follow up on CAPAs.  Participate in audits, inspections, 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 be the request sites.  Being 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 lead 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.  Collaborate with stakeholders regionally for inspection preparedness.  About you   Experience: 4+ years of Compliance or Auditing experience.  7-10 years of related experience in the pharmaceutical industry.  Thorough knowledge of cGMPs, Code of Federal Regulations in drugs and biologics  Should be knowledgeable in Quality functions of 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 application of GMP requirements  Experience managing third party manufacturers and/or contract manufacturer organization is preferred.  Experience of working on manufacturing sites is an added advantage.  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 English language (spoken and written). Why choose us? Bring the miracles of science to life alongside a supportive, future-focused team in an international work environment Work from an "Office of the Year 2025" award winner with flexible home office policy 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 An individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your first weeks Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs) Office of the Year 2025 – Evolution Award Our most recent award – Sanofi is recognized for creating an innovative workspace that supports collaboration and adaptability. Marketing Diamond Award 2026 – Employer Branding One of the highest honours at Hungary's prestigious Marketing Diamond Awards, recognizing excellence in employer branding. BSC Investor of the Year 2025 Awarded by HIPA, ABSL Hungary, and AmCham Hungary for our contribution to Hungary's business services sector. PwC Workforce Preference Survey 2025 – Top 3 Most Attractive Employers Ranked 3rd among the most attractive employers in Hungary. Hungarian Employer Branding Awards 2025 – Gold & Silver Best Strategic Employer Branding Campaign (Gold) and Best Employer Branding Campaign in the Pharma Sector (Silver). Pursue Progress. Discover Extraordinary. 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.   Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! Discover our Code of Conduct, that serves as the moral compass that guides us when chasing the miracles of science to improve people’s lives. Please ensure to have read this document before applying. #Sanofi #SanofiCareers #joinSanofi #jobopportunities #careeropportunities #sscjob #Sanofi_Budapest_Hub #Budapest #R&D #LI-EUR #LI-hybrid 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 and check out our Diversity Equity and Inclusion actions at sanofi.com! The salary range for this position is :Ft10 944 000,00 - Ft14 592 000 Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.