Chef principal, Assurance Qualité Clinique
Core
Senior Clinical Quality Assurance leader ensuring regulatory compliance and data integrity for clinical trials across Europe, Americas, and Intercontinental regions to support AbbVie's R&D and market authorization goals.
Role type
Senior IC clinical quality assurance manager (associate director level)
Builds
Clinical trial quality systems, regulatory submissions, and inspection readiness for global R&D
Domain
Biopharmaceuticals / Clinical Research / Regulatory Affairs
Required skills
Clinical trial quality management, regulatory compliance, risk mitigation, audit execution, inspection preparation, CAPA management, data integrity, strategic quality planning, cross-functional leadership
Preferred skills
Multilingual capabilities, travel adaptability
Technologies
Quality management systems, regulatory databases
Responsibilities
Maintain collaborative relationships with subsidiary RDQA functions and clinical development teams; supervise quality and compliance in regulated environments; lead risk identification and mitigation strategies for clinical research; define quality KPIs and pilot quality strategies; manage governance aligned with One AbbVie Quality System; ensure consistent understanding of quality requirements; maintain updated knowledge of applicable regulations; support supplier visits, audits, and provider qualifications; develop inspection strategies and support local/regional health authority inspections; conduct audits to evaluate regulatory compliance; support robust responses to audits and inspections; mentor AREA Managers/Associates or exercise leadership responsibilities.
Seniority
Senior, hands-on IC with leadership scope
