Executive Director of Clinical Quality

The Company is seeking an Executive Director of Clinical Quality to lead its Clinical Quality Assurance team and ensure clinical programs meet Good Clinical Practice (GCP) and regulatory standards. Responsibilities include planning and overseeing audits of clinical sites, vendors, and internal systems; reviewing audit reports; and partnering with cross-functional teams to investigate findings and implement corrective and preventive actions. The role also develops audit plans, maintains tracking systems and management metrics, and provides guidance and training for regulatory inspections and clinical investigator meetings. The successful candidate will support consistent quality standards across clinical development activities. Candidates must hold a bachelor’s degree in nursing, health science, or a related field and have at least 15 years of experience in clinical auditing and compliance, including executive-level expertise. Strong knowledge of GCP auditing and U.S. and ICH GCP regulations is required, along with experience assessing investigational sites, clinical reports, and vendors. Familiarity with clinical safety and trial management systems is also expected. Excellent communication, organizational, and project-management skills are essential, as is the ability to manage competing deadlines and travel as needed.