Job title: Senior Auditor / Senior Manager- Global M&S Services

Location: Budapest, Hungary

50% of travel expected: Travel required as per business need

Job type: Permanent and Full time

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 Auditor / Senior Manager for the 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. Your job? You will be responsible for acting as auditor supporting the M&S organization in carrying out tasks and fulfilling responsibilities to facilitate the identified and established global quality processes from the hubs.

• Leads and defines the priorities and deliverables of Hubs, fostering a culture of quality and collaboration.
• Provide Technical Support to Third Party Manufacturers and Contract Manufacturer Organizations, 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/CMO location and markets.
• Manage supplier audit programs and follow-up on regulatory audits.
• Provide an assessment of supplier's quality in place with regards to material compliance, as well as regulatory of CAPA for Third Party sites.
• Support audits lead by other auditors when specific expertise is needed.
• Collaborate with stakeholders regionally for inspection preparedness.

• Experience: 6-10 years in highly regulated medical industry (pharma is desirable), minimum 4 years of Quality, Regulatory & Compliance or Auditing experience (incl. preparation or conducting on-site audits). Experience of supporting inspections and facing regulatory/health authority inspections/audits considered as added value, application of GMP requirements is a must. Willingness to frequent travel (up to 60%) as per business need.
• Technical skills: Knowledge of cGMPs, 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: Passionate, agile, ready to take action. Great problem solving and decision-making skills, proficient in problem-solving, attention to detail and good organizational skills.
• Education: Master's or Ph.D. in Life Sciences/Healthcare, or related technical field.
• Languages: Excellent knowledge of English language (spoken and written). Other European languages are desirable.

• An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team.
• An attractive, market-oriented salary and cafeteria benefits.
• Flexible home office policy, with a possibility to work up to 60% of time from home / where you can easily schedule your office days.
• Work from an "Office of the Year 2020" finalist office.