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Job title : Auditor / 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 Auditor / 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.

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: 4+ years in highly regulated medical industry (pharma is desirable), minimum 2 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.

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.

Pursue Progress . 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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !

Discover our Code of Conduct (https://protect-de.mimecast.com/s/0iy3CXQyOpFqkyZ03S6XcFz?domain=protect-eu.mimecast.com/) , 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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#SanofiBudapestHub #Budapest

#LI-EUR #LI-Hybrid

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, ability or gender identity.

Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)

As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.

All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)