Sr. Clinical QA Manager
Neurocrine Biosciences
Responsibilities
- Lead planning, conducting, and overseeing GCP audits for vendors, investigator sites, and internal operations
- Develop audit execution plans including resourcing, consultant oversight, and stakeholder communications
- Serve as Clinical QA Lead for complex programs and develop risk mitigation strategies
- Provide GCP training and guidance on remediation and corrective action plans to study teams
- Standardize clinical development processes through SOP preparation and implementation of quality systems improvements
Requirements
- Bachelor's degree in life sciences or related field, or RN credential with 8+ years industry experience including 4 years clinical QA
- Master's degree in life sciences with 6+ years relevant clinical QA and drug development experience
- Expertise in FDA regulations, ICH Guidelines, and international GCP requirements
- Demonstrated ability to design and execute comprehensive audit programs for investigator sites and vendors
- Leadership and mentoring skills with ability to manage multiple teams and projects
- Advanced project management, analytical, and problem-solving capabilities
- Gene therapy clinical trial experience preferred
Vacancy posted 6 days ago
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