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?

• 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.

•

• 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.

•

: 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)