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

Hely: Budapest
Cég: Sanofi
Kategória: Gyártás, Termelés

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. 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 biologicsShould 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 desirableThorough knowledge of and experience in application of GMP requirementsExperience 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 fieldLanguages: Excellent knowledge of English language (spoken and written). 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 policyEnjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impactTake 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 leaveAn individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your first weeksJoin a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs) Office of the Year 2025 – Evolution AwardOur most recent award – Sanofi is recognized for creating an innovative workspace that supports collaboration and adaptability.Marketing Diamond Award 2026 – Employer BrandingOne of the highest honours at Hungary's prestigious Marketing Diamond Awards, recognizing excellence in employer branding.BSC Investor of the Year 2025Awarded 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 EmployersRanked 3rd among the most attractive employers in Hungary.Hungarian Employer Branding Awards 2025 – Gold & SilverBest 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.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.

Címkék: Employee status, College

profession.hu - 5 napja

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