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

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 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 partners to M&S organization in carrying out tasks and fulfilling responsibilities to support identified and established global quality processes from the hubs. (Travel is required as per business need).

Main responsibilities:

• 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.

About you

• Experience: 7+ years in Compliance or Auditing, 10 – 13 years in the pharmaceutical industry, conducting on-site audits, inspections and facing regulatory/health authority inspections/audits, application of GMP requirements

• 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:Excellent problem solving and decision-making skills, risk-based decision-making ability, proficient in problem-solving, attention to detail, proactive, 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).

Why choose us?

• 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.

PursueProgress. 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.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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.

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