Quality System Commercial Operations Coordinator

il y a 1 semaine


Greater Paris Metropolitan Region, France Excelya Temps plein

I. Excelya


Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care. We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 900 Excelyates. Our unique one-stop provider service model – leveraging full-service, functional service provider and consulting – allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journ For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field.

We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.



II. Missions


1 - Deploy QMS across Commercial Operations groups efficiently:

  • In charge of the definition of QMS for Commercial Operations in collaboration with other functions having GxP related activities
  • As Document Manager guide process owners, authors, and users regarding the quality document review process (e.g. use of Easidoc) including training strategy.


2 - Ensure GxP compliance:

  • Drive remediation plans when a product quality or GxP process issue is identified.
  • Responsible for the implementation of Quality Management Reviews for a dedicated area


3 - Foster Quality culture:

  • Encourage best practices (“Quality beyond compliance”, specifically from a continuous improvement perspective).
  • Maintain structured customers/stakeholder’s communication between local Ipsen sites/functions and the corporate ones to improve integration.


4 - Support sites & business units:

  • Focus on proactive crisis prevention and efficiency support crisis management (QSEB) and CAPA follow-up when needed.
  • In charge of APQRs communication to MAH on a timely manner


Profile

You have a Life sciences Master degree (pharmacy, chemistry, biology) with significant, appropriate experience of 2 years in international pharmaceutical quality management, practical GxP experiences as well as working in matrix organization is an asset so is working in Commercial Operations environment.



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