Director, Clinical Quality Assurance - Eisai : Job Details

Director, Clinical Quality Assurance. The Director, Clinical Quality Assurance position is responsible for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisais Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US, EU Directives, US FDA, PMDA, ICH). Essential Functions - Independently conduct audits - Review and oversee results of CQA audits of study sites, clinical vendors, clinical documents, and internal process audits - Facilitate Sponsor health authority inspections of global clinical facilities and study sites - Continuously drive innovation through active search, evaluation, acquisition, and implementation of high-impact new technologies/ pr...Quality Assurance, Director, Clinical, Quality, Assurance, Clinical Research, Technology