China Sr. Manager, Quality Management, Training, & Compliance (QMTC)
Core
Establish and maintain a sophisticated Quality Management (QM) framework for China R&D to ensure clinical studies are conducted with high quality and regulatory compliance.
Role type
Senior Manager, Quality Management & Compliance
Builds
Quality management systems, training curricula, and audit response strategies for China R&D
Domain
Pharmaceutical industry, Clinical Research, Regulatory Compliance (China & Global)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Management System (QMS) design, Clinical Quality Risk Management, ICH-GCP knowledge, Local regulatory compliance (China), Training curriculum development, Audit response management, Process improvement, Data-driven trend analysis
Preferred skills
Health-related degree (Medical, Scientific, Nursing, Pharmacy), Quality by Design principles, Risk-based monitoring, Change management, Project management
Technologies
Learning Management System (LMS), Issue management tools, Risk management tools
Responsibilities
Develop and oversee the quality system and associated strategy; Lead impact assessments for new local regulations; Identify and plan instructor-led training needs; Review and refine training curriculum; Provide advice on clinical processes and international guidelines; Lead audit response management and review CAPAs.
Seniority
Senior, hands-on IC with leadership responsibilities
