Country Clinical Quality Lead
La empresa dio por finalizado este aviso.
Main Responsibilities:
· Responsible for the Development, Implementation & Maintenance of a Quality management system to demonstrate active Quality Management within the Country Clinical Operations
· Ensure adherence with local regulations leads development of Local Implementation guidelines where required.
· Partnering with Internal and external quality roles, local Quality compliance roles, drives Implementation of SOPs, processes, systems & training at the country and ensure Local Inspection Readiness.
· Provide vendor oversight including conduct of assessment visits in collaboration with local Monitoring management.
· Manages compliance with implementation
· Ensures the timely & effective implementation of the Dev Ops compliance plan
· Provide support for QA for Clinically related local Audits & inspections, coordinate audit responses and closure
· Manage correct assignment of country staff to Global curricula.
· Develop and maintain local training curricula .
· Maintain intelligence regarding local regulations and GCP to disseminate and educate local CO staff as appropriate.
Education
Required:
BS/BSc/MS/MSc or equivalent + 3 years of clinical research and quality management experience
Preferred:
Graduate degree related to drug development / A scientific or technical degree is preferred.
Relevant Experience
· Experience in developing quality management plans
· Experience with SOP and training implementation
· Experience with diverse needs of regulatory requirements from different countries
· Experience of conducting, managing or participating in an audit process
· Experience with drug development, monitoring and/or QA experience, and inspection readiness
· Experience managing multiple complex projects
· Experience implementing centrally designed and developed processes and procedures on a local basis
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