Clinical Quality Manager - Boulogne-Billancourt, France - Excelya

Excelya

Entreprise vérifiée

Boulogne-Billancourt, France

il y a 2 semaines

Posté par:

Sophie Dupont

beBee Recruiter

Description

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.

Context:

We propose an exciting mission to work in a dynamic and international and transversal environment and to participate to maintaining an effective and efficient Quality Systems for the operational units involved in clinical research:

Participate to Vendor's Quality Assurance Meetings and ensure quality oversight
For the clinical studies assigned, works with the Clinical Research project manager to ensure good clinical practices and relevant regulatory requirements are met
Participate to Vendor's Quality Assurance Meetings and ensure quality oversight
Report CAPA status and metrics, escalating any issues regarding delayed timelines or ineffectiveness of CAPA, as needed
Ensure timely delivery by following up with CAPA owners and scheduling meetings as necessary
Ensures documentation, investigation, and tracking of major deviations and potential Serious Breaches in GCP
Organize and coordinate deviation assessment meetings, providing meeting minutes and ensuring communication and escalation as appropriate
Perform Risk Assessment and ensures communication to management and consolidation in the tracker.
Support the audit activities: provide information to audit group for their risk assessment and audit activities, facilitate further investigation of observations (when needed), root cause analysis and definition of CAPA.
Assist in the preparation and conduct of inspection as required.
Guide system users to ensure they are trained when required
Develop and communicate Corporate Quality Objectives applicable to clinical research.
Shares major deviations and serious breaches with the organization to ensure prevention across organization and alignment of CAPA

Skills and Experience:

Minimum 5 years' experience in Quality Assurance in the pharmaceutical industry in management of quality system
English required.
Ability to produce high quality and accurate work within deadlines.
Good organization and management skills, able to prioritise work.
Able to work and integrate in matrix organization

Summary: