Responsable Assurance Qualité cliniques F/H
Core
Clinical Quality Assurance lead ensuring regulatory compliance for clinical trials and driving continuous improvement of the quality system.
Role type
Senior Clinical Quality Assurance Manager
Builds
Regulatory-compliant clinical trial operations and quality management systems
Domain
Pharmaceutical/Clinical Research
Required skills
CAPA management, root cause analysis, regulatory inspection preparation, internal/external audit coordination, risk management, ICH-GCP expertise, SOP development, team training
Preferred skills
Experience in pharmaceutical/biotech/CRO environments, knowledge of ANSM/EMA/FDA requirements
Technologies
None stated
Responsibilities
Pilot deviation and CAPA management, conduct root cause analyses, prepare for regulatory inspections, coordinate audits, identify quality risks, ensure ICH-GCP compliance, develop quality documentation, train operational teams
Seniority
Senior, hands-on IC
