Director, Clinical QA

Role: Head of Clinical Quality Assurance at Neurocrine Biosciences, responsible for developing and executing the clinical QA strategy, establishing compliance frameworks, and leading a team of QA professionals. Core responsibilities include overseeing GCP compliance, managing internal and external audits, supporting regulatory inspections, and enhancing the clinical Quality Management System across Phase I-IV trials, with a focus on neuroscience and related therapeutic areas. The role involves collaboration with Clinical Development, Regulatory, Drug Safety, and Clinical Operations teams to ensure adherence to global GCP/regulatory standards and facilitate regulatory submissions. Requirements: RN, BSN, BS/MS, or BA with 12+ years of industry experience in GCP environments, including extensive audit and inspection expertise; managerial experience necessary. Preferred qualifications include recognized thought leadership, advanced knowledge of FDA/EMA regulations, and experience with biological, gene therapy, or neurological programs. High-Value: Leadership in clinical QA within biotech/pharma, GCP compliance, experience with multi-phase clinical trials, regulatory inspection readiness, and global QA systems. The position is based remotely, with a focus on building a strong quality culture across functions.