Quality Manager System – France

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 800 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 journey.

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.

What we offer:

• Keep informed of any implementation or modification of international and/or national regulations/guidelines related to its activities within R&D GxP standards, and propose appropriate actions (e.g. modification of QDs, processes).
• Provide appropriate support and guidance to relevant personnel in ensuring the implementation of quality policy and quality documents.
• Assume the role of Quality Document Owner (QD Owner) or participate as QA representative in the creation and updating of QDs supporting processes and their owners.
• Ensure that regulatory and ICH requirements are taken into account in QDs, where appropriate, and coordinate their drafting, updating and validation in accordance with central policy and QDs.
• Provide guidance and assistance to R&D staff in the implementation of their training process.
• Create/update quality training materials (GCP, quality guidelines and regulations) and participate in the training of R&D personnel.
• Contribute to Quality Risk Prevention (definition, follow-up and maintenance) for projects for which he/she is responsible, in collaboration with other R&D QA divisions and relevant structures.