Clinical Quality Manager
Primary Location: China, Shanghai Shinmay 求人ID R0000041777 Category Quality Management
About this Role
Key Accountabilities:
Act as a point-of-contact (POC) and subject matter expert (SME) for clinical quality requirements and activities in China for assigned portfolios, studies, or vendors.
Implement strategies and activities related to inspection readiness and audit response management for clinical development conducted in China.
Lead the development of Risk/Quality Plans for Development China functions and the China clinical trial portfolio and associated key vendors when needed.
Support GCP quality event reporting, assessment, investigation, and remediation activities for GCP quality issues related to China clinical development activities.
Develop and deliver GCP quality relevant training as needed
Minimal Requirements:
A scientific or technical degree; an advanced degree (MS/MD/PhD) is preferred.
Extensive clinical development and business experience that demonstrates a thorough understanding of the processes associated with clinical and regulatory operations.
Knowledge of local and international regulatory requirements, especially intensive experience in CFDI/FDA Inspection.
At least 5 years of increasingly responsible positions in Clinical Operation and/or Clinical Development Quality.
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