GCP Quality Manager

Job title : GCP Quality Manager
Location : France
Job type : Contract/Freelance
Salary : Negotiable
Contact name : John Swift
Contact email : john.swift@secpharma.com

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 project meeting and ensure timely assistance and escalation for all quality related topics in relation to the conduct of the study
Participates to the vendors' selection and Quality Assurance Meeting and ensure quality oversight in relation to the studies outsourced.
Escalate to Manager identified issues that need to be discussed during the oversight and steering committee.

Participate to monitoring of quality documents revision for all key aspects of the process, including timelines, training material availability, and communication to key stakeholders
Manage the review/approval process, track and report status.
Ensure timely delivery by monitoring progress, conducting meetings and escalating as appropriate.
Maintain an inventory (e.g. mapping / list) of all quality documents related to the conduct of clinical research, including planned review dates and the status of all SOPs being revised
Liaise with Document Manager and customers to ensure collaboration and efficiencies
Corrective and Preventive Actions (CAPA):
oFacilitate operational units' development, and tracking to timely completion, of Corrective and Preventive Actions, contributing to root cause and risk analysis of clinical research matters, and assisting in establishing the effectiveness of implemented CAPA.
oReport CAPA status and metrics, escalating any issues regarding delayed timelines or ineffectiveness of CAPA, as needed
oEnsure timely delivery by following up with CAPA owners and scheduling meetings as necessary
Deviations and major breach
oEnsures documentation, investigation, and tracking of major deviations and potential Serious Breaches in GCP
oOrganize 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.
Foster a culture of continuous process improvement by monitoring CAPA effectiveness and facilitating Quality Risk Management activities
Ensure lean principles are taken into consideration for all quality management system activities
development of any other Global R&D Quality Assurance tool either as a coordinator with relevant functions or as an SME, aimed at describing and harmonizing Global safety QMS and/or Global R&D Quality Assurance activities.

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.
Provide responses and address questions and observations during inspection when observations are related to the role or responsibilities of the QA function.
Assist in the preparation and conduct of inspection as required.
Contribute to training sessions as SME, by reviewing training materials or participating in presentations where needed.
Guide system users to ensure they are trained when required (e.g. when a specific training task is required in ILearn)
Liaise with process owners and trainers to ensure appropriate training material is generated and made available for clinical research activities.
Develop and communicate Corporate Quality Objectives applicable to clinical research.
Serves as liaison between the Global Quality System department and functional entities involved in clinical research.
Shares major deviations and serious breaches with the organization to ensure prevention across organization and alignment of CAPA


This is an urgent position, so if please contact me on john.swift@secpharma.com for more information.