Sr. Clinical QA Manager

Role: Lead Clinical Quality Assurance (CQA) activities supporting research and development across multiple therapeutic areas at Neurocrine Biosciences, focusing on GCP compliance for clinical trials. Responsibilities include planning, conducting, and overseeing GCP audits (vendor, investigator sites, internal), developing audit strategies, managing audit documentation, and supporting regulatory inspection readiness. The role involves serving as the CQA lead on complex programs, developing risk mitigation strategies, and providing GCP training. Additionally, the position entails advancing quality systems, monitoring GCP metrics, and collaborating with cross-functional teams to drive continuous improvement and compliance initiatives. Requirements: BA/BS in life sciences or RN with 8+ years of industry experience, including 4+ years in CQA; or master's degree with 6+ years in similar roles. Proven expertise in GCP regulations, clinical audits (Phases I-IV), and regulatory guidance is essential. Preferred: experience with gene therapy trials and international GCP standards. The role demands strong leadership, communication, and project management skills, with an emphasis on audit execution, regulatory familiarity, and cross-functional collaboration. The position may involve supporting multiple teams, with a focus on maintaining high standards of compliance for both research and commercial clinical programs. Work setup details are not specified.