Sr. Director, Research and Development Quality Assurance

Role: Senior Director of RQA responsible for leading GCP/GLP/GVP Quality Operations at Akebia, ensuring high-quality execution of non-clinical and clinical trials from early phases to commercialization. Responsibilities: oversee quality management, develop and implement strategic quality objectives, foster cross-functional collaboration, ensure regulatory compliance, manage inspection readiness, and interact with regulatory agencies. Lead and coach domestic and external teams, develop strong relationships across departments and vendors, and guide risk mitigation and CAPA processes. Requirements: bachelor’s in a scientific discipline; 10+ years in pharmaceutical/biotech GCP, GVP, GLP environments; 8+ years of management experience. Preferred: advanced scientific degree, comprehensive knowledge of GCP/GLP/GVP regulations, and understanding of clinical and non-clinical research processes. High-Value: oversight of quality in clinical development, regulatory interactions, inspection readiness, and strategic quality leadership. Work setup: hybrid model based in Waltham; travel approximately 25%, including international trips.