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

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

Location:

Budapest, Hungary

Approximately 30% of travel expected

Job type:
Permanent, full time

Hybrid working (60% office, 40% home)

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 Senior Manager Quality Services and you can help make it happen. 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.

Your job? You will be responsible for acting as partners to M&S organization in carrying out tasks and fulfilling responsibilities to support identified and established global quality processes from the hubs.

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 working on manufacturing sites is an added advantage.

Technical skills:

• Knowledge of cGMPs.
• Knowledge of Code of Federal Regulations in drugs and biologics.
• Knowledge of CAPA systems is required and experience is desirable.
• Knowledgeable in Quality functions of pharmaceutical industry.

Soft skills:

• Excellent problem solving and decision-making skills are critical to this position.
• 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
• 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…