Expert Assurance Qualité Projets Cliniques - CDI - (H/F)
Core
Define and apply clinical quality strategy, ensure regulatory compliance, and manage quality for clinical projects and R&D development.
Role type
Senior Clinical Quality Assurance Expert
Builds
Clinical study documentation, quality management systems, audit programs, and supplier quality controls for pharma R&D.
Domain
Pharmaceutical industry, Clinical Development, Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical Quality Assurance, GCP (ICH E6), GVP, GDPR, Risk Based Quality Management, Regulatory Inspection preparation, Supplier Quality Management, Clinical Project Management
Preferred skills
GMP, GLP, GDP, FDA/EMA/ANSM/MHRA regulatory expectations, eTMF systems
Technologies
eTMF, electronic quality management systems
Responsibilities
Define clinical quality strategy and ensure regulatory compliance; Review and approve clinical documentation (protocols, monitoring plans, reports); Conduct or coordinate audits of systems, processes, suppliers, and clinical sites; Manage supplier quality for CROs and external partners; Prepare for and accompany health authority inspections; Monitor CAPAs and root cause analyses.
Seniority
Senior, hands-on IC
