Quality officer operator – 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:

Quality management system for the operating site
– Design and implementation of Quality Assurance policy
– Ensures that the Quality Management System (QMS) complies with applicable standards (GMP, BPD, ISO, etc.).
– Define, implement and monitor the audit plan (internal and external) with various internal and external partners.
– Quality monitoring of subcontractors within the scope of the operating site’s activities, including Quality Assurance, Pharmacovigilance, Medical Information and Regulatory Affairs.
– Management and coordination of ANSM inspections and Group or external partner audits
– Quality documentation management – Drafting or coordinating the drafting of procedures by business experts, recording them in the document management system, distributing them and monitoring awareness of them.
– Definition and monitoring of KPIs
– Coordination of initial and ongoing employee training, traceability and monitoring of knowledge acquisition.
– Participation in continuous improvement and simplification initiatives – Support for business development via the change management process (change control): coordination and follow-up of change requests
– Risk management: anticipation (risk mapping); risk identification, control and alerting of regulatory authorities
– Identification and recording of non-conformities (deviations/anomalies), assessment of criticality and search for causes with the departments concerned, initiation and follow-up of associated action plans in collaboration with business experts.
– Management of CAPAs (definition, follow-up) in collaboration with business experts
– Preparation and organization of management reviews (annual quality review) and follow-up of defined actions.
– Define and implement communication plan for quality policy and program.
– Steering of the product quality complaint management process: assessment of initial criticality and recurrence, implementation of immediate actions for critical complaints.
– Reporting to Management & Global QA Team

You will be responsible for liaising with the relevant authorities (ANSM) and answering questions on inspections, quality defect reports, stock shortages, etc.

You will also be responsible for coordinating and submitting the inventory of pharmaceutical establishments for SAS, working closely with the Delegate Pharmacists production and distribution sites in France.

Certification of medical visits
– Supervision and coordination of the implementation of the requirements of the certification guidelines, in collaboration with the various departments involved, as well as with the service providers in charge of promotional information.
– Preparation, organization and follow-up of certification audits (initial and follow-up)
– Preparation and review of specifications, organization and traceability of training courses (initial and continuing training, role-playing sessions) and accreditation of scientific and medical managers (SMRs).
– Coordination and management of the annual quality review specific to promotional information.