CHC Distributors Quality Lead – Europe Region

Location: Budapest (Hungary)

50% Remote working

Job type: Permanent, Full time

About the job

We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across around 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the centre of our ambitions.

As CHC Distributors Quality Lead, you will support the Business Teams in charge of the management of Distributors (in the assigned countries selected for a Distributor Business Model set-up) by ensuring an appropriate quality oversight/level of control on those Distributors.

Main responsibilities

• Operational management of all quality matters reported by/impacting the local Distributors marketplaces, in full compliance with applicable regulatory requirements and company standards: Product Complaints, Quality events, Recalls, Temperature excursions
• Coordination across SANOFI CHC in relation to activities executed by the Distributors in scope:Repackaging/Redressing operations, Quality Control testing support
• Contribution to the assessment of the CHC Product Quality Reviews (PQRs) by the Marketing Authorization Holder (MAH) in the “Distributors Business Model countries” where SANOFI CHC is MAH, in compliance with applicable requirements
• Management of Changes impacting the assigned Distributors. For change requests coming from distributors: follow-up of the implementation
• Quality management of assigned Distributors
  • Qualification/Quality assessment of Distributors
  • Regular operational meetings with Distributors, Annual Quality Review
  • Training of Distributors personnel to SANOFI CHC processes & ways of working
  • Annual review/update of Quality Agreements with Distributors, as well as with manufacturing sites and MAH for distributors markets
  • Analysis of the outcomes of the audits of the Distributors, ensure that efficient action plans are defined, implemented and followed-up until closure by the auditors
  • Annual evaluation of Distributors Quality performance
  • Support to Distributors in case of inspection by local Heath Authorities (GDP, GMP)
  • Qualification of manufacturing sites by distributors when MAHs
• Contribution to CHC Global Quality Projects with impact on Distributors (as needed)

About you

Experience:

• operational experience “on the field” in quality system management, ideally in the distribution area

Soft skills:

• advanced level in: “Commit to customers”, “Cooperate transversally”, “Business partnering”
• advanced networking capabilities (internal & external)
• excellent communication (written & oral)
• strong interpersonal relationships, team spirit
• savvy for working in a multi-cultural & international environment

Technical skills:

• Advanced knowledge in GxP (mainly GDP, GMP) regulations, in quality risk analysis/management, quality system management
• Knowledge in Pharmacovigilance (GVP) and health-regulated e.g. (Regulatory Affairs, Medical Information) regulations would be additional assets

Education:

• Degree in health care/life sciences (such as Pharmacist, Engineer …)
• Additional degree in health care goods quality management is an asset

Language:

• fluent working English, any additional language would be a plus

What we offer

• 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 aligned with your qualifications
• An individual and well-structured introduction and training of new employees
• Professional career opportunities in dynamically developing working environments
• Flexible home office policy, with a possibility to work up to 50% of time from home; where you can easily schedule your office days
• Yearly medical check-up
• Collective life and accident insurance

If the description fits your experience and has captured your interest, please apply so we can get in contact with you!

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.

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, disability, or gender identity.

Pursue Progress, Discover Extraordinary.

Visit our external career site for more opportunities and information: 

https://www.sanofi.hu/hu/karrier

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.