Director, Clinical Quality Assurance

Neurocrine Biosciences, a prominent biopharmaceutical organization focused on neurological, psychiatric, endocrine and immunological disorders, seeks a Director of Clinical Quality Assurance to shape and oversee its quality framework for clinical programs. The role sits at the intersection of regulatory, clinical and medical affairs, guiding the company’s mission to deliver life‑changing therapies. The incumbent will craft and execute the Clinical QA strategy, build and manage a team of quality managers and specialists, and ensure that all clinical activities adhere to GCP standards. Core duties include preparing for and participating in regulatory inspections, directing pre‑approval audits, coordinating risk‑based quality initiatives across departments, and overseeing audits of investigators, contract labs and CROs. The director also drives the development and continuous improvement of the clinical quality management system, monitors drug‑safety compliance, and generates metrics to report compliance trends to senior leadership. Candidates must hold an RN, BSN, BS/MS, BA or equivalent scientific/health‑care degree, or a master’s degree in a related field, combined with at least ten to twelve years of industry experience that includes senior GCP leadership roles. Proven expertise in conducting GCP audits and inspections, designing and implementing QA systems, and managing teams is required. Strong interpersonal abilities, confident communication with regulators and internal partners, and a track record of mentoring and advising on quality matters are essential. The position offers the chance to influence a high‑performing, strategically driven environment, collaborating with cross‑functional leaders and external stakeholders while supporting a robust pipeline of innovative therapies.