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Director, Clinical QA
Job in
San Francisco, San Francisco County, California, 94199, USA
Listed on 2026-10-09
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-10-09
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
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:- Overseeing GCP compliance
- Managing internal and external audits
- Supporting regulatory inspections
- 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.
- Recognized thought leadership, advanced knowledge of FDA/EMA regulations, and experience with biological, gene therapy, or neurological programs.
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.
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