Purpose: Establish sophisticated Quality Management (QM) framework in China R&D that consists of quality elements such as processes, issue management, risk management and knowledge management
Ensure clinical studies are conducted in China with high quality and in compliance with regulatory requirements and standard procedures by adopting the above QM framework
Responsibilities:
- Exercise leadership over discussions regarding quality in China and contribute to maintaining high level of quality
- Develop, maintain, and oversee the quality system and associated strategy, processes, tools, and technologies
- Perform local business process management in alignment with global/local regulatory requirements
- Lead impact assessment (IA) discussions around new/updated local regulations as well as Global QSDs in collaboration with the IA team members
- Identify training needs based on data-driven decisions. Plan and provide instructor-led training needed from a QM perspective targeted for China R&D and/or Global audience as applicable
- In consultation with China R&D leadership, review and refine training curriculum for local roles in the Learning Management System
- Provide advice to China R&D including global/local clinical processes, procedural documents and on international guidelines such as ICH-GCP, industry standards and local regulations
- Explore more efficient ways in improvement of quality and implement that in collaboration with stakeholders through process management, training and other quality activities
- Lead audit response management and review quality issues and audit/inspection CAPAs to ensure suitability