Director, Clinical Quality Assurance
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer’s disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Job Profile Summary 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 Eisai’s 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 - Oversee and guide conduct 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 - Provide skill-building interventions for CQA staff through cross-functional/ external partnerships to reskill/ upskill and adapt the workforce to evolving technologies - Potential for direct people management Requirements - Bachelor's degree in an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research or operations or related area. Prior experience in site monitoring and study management is preferred. - Strong knowledge of multiple therapeutic areas, eg. neuroscience and oncology, and ability to translate key protocol objectives into auditable activities - 5+ years of experience in GCP auditing - Substantial experience in inspection management - Substantial experience with US, EU, and