Quality Project Management Officer - VIE Contract

Looking to launch your career at the cutting edge of healthcare? Join Sanofi for a chance to develop with mentoring and guidance from inspirational leaders while helping to make an impact on the lives of countless people worldwide. As Quality Project Management Officer VIE in our Multi Country Organization (MCO) North Europe team, you’ll will work not only in close collaboration with the Country Quality Head of Norway, but also supporting North Europe Quality Head in operational project work for Quality, especially related to our documentation system and related training.

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?

Main responsibilities:

• Working in close collaboration with the concerned functions responsible for these activities in their area i.e. managing and supporting the quality system used for the management of Quality documents, setting up training plans, supporting the marking of training, supporting with communication to enhance our quality culture.
• Contribute to the management and maintenance of the Country Quality Management System.
• Handling of Product Technical Complaints according to company process under the supervision of the Country Quality Head (CQH).
• Provide support to the CQH in all product quality/technical matters and GxP related activities such as quality deviations, quality events, quality alerts and recalls of medicinal products from the market.
• Evaluate and maintain correct handling of temperature deviations of transportation or storage of Products.
• Work in compliance with EU GDP, “Reflection paper on good manufacturing practice for marketing authorization holders” and local legislation and belonging regulations as applicable.
• Prepare Product Quality Review documentation and evaluate as Market Authorization Holder (MAH).

About you

Experience:

• Strong knowledge and experience in quality management system.
• Solid experience in GxP particularly Good Distribution Practice (GDP) and Good Manufacturing Practices (GMP) areas & other health regulation applicable in Pharmaceutical industry.

Soft and technical skills:

• Well-organized, strong written and oral communication skills and ability to manage multiple priorities & urgencies, and to adapt easily and quickly to changing situations and priorities.
• Ability to work transversally in a matrix organization and to foster a process simplification approach while meeting compliance requirements.
• Great presentation, listening, and analytical skills, having a problem-solving attitude, being attentive towards details, good team player & a quick learner.
• Knowledge of various IT tools: MS Office; Sharepoint and MS projects experience would be a plus.
• Knowledge and/or experience in (communication) tools, animation of Communities, digital media and of QualiPSO tool (document management system) would be an asset.

Education:

• Master’s Degree in Pharmacy or science (e.g. biomedical science, pharmaceutical science, chemistry) or similar field.

Languages:

• Fluency in English language, knowledge of Scandinavian language/s would be a plus.