Sr. Director, Clinical QA
Neurocrine Biosciences
Neurocrine Biosciences seeks a Sr. Director of Clinical QA to develop and lead clinical quality assurance strategy, ensuring GCP compliance across the clinical development portfolio. This role provides strategic quality oversight, regulatory inspection leadership, and guidance on complex compliance matters across clinical development functions.
Responsibilities
- Develop and execute multi-year clinical QA strategy aligned with company and R&D objectives
- Lead regulatory inspection readiness, inspections, and compliance activities across global clinical trials
- Provide strategic quality guidance to clinical development, operations, and regulatory functions on complex compliance issues
- Establish and oversee risk-based audit strategies for investigators, CROs, laboratories, and external partners
- Direct development and continuous improvement of the clinical Quality Management System
Requirements
- Extensive clinical quality assurance and GCP compliance experience in biopharmaceutical industry
- Demonstrated strategic leadership of quality functions and cross-functional teams
- Deep knowledge of global regulatory requirements and clinical trial oversight
- Experience managing regulatory inspections and audit strategies
- Proven ability to develop quality management systems and policies
- Track record of building organizational capabilities and talent development
Vacancy posted 2 days ago
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