M&S Services, Manager Quality Services, Third Party Audits Budapest

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 drive priority and transformative initiatives across M&S. The team members of Global M&S Services Hubs will act as partners 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 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.

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’sor Ph.D. in Life Sciences/Healthcare, or related technical field

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, disability, or gender identity. 

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