Establish sophisticated Quality Management (QM) framework in China that consists of quality elements such as processes, issue management, risk management and knowledge management.

Conduct qualification oversight assessment and activities for the identification of risk related to the performance of China CSM (Clinical Site Management) and China Development

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

·       Develops, maintains, and oversees the quality system and associated strategy, processes, tools, and technologies for China CSM and China Development

·       Performs local business process management in alignment with global/local regulatory requirements

·       Leads the team to identify factors (Processes and data) that are critical to quality and to proactively identify, prioritize, and manage important risks to quality

·       Leads the team to identify country level quality issue, set proper thresholds, and consistently oversee and manage performance

·       Provides advice to the team including global/local clinical processes, procedural documents and on international guidelines such as ICH-GCP, industry standards and local regulations

·       Oversees quality issue escalation, assessment, investigation, and remediation activities.  Oversight country level metric related quality

·       Owns and manages the strategy and activities related inspection readiness for clinical trial conduct in China.  Partners with RDQA to prepare for and management GCP regulatory inspections.  Leads audit response management and review quality issue and audit/inspection CAPAs to ensure suitability

·       Identifies training needs for China based on data-driven decision.  Plans and provides training needed for QM of clinical studies in China.  Review and update training curriculum in the Learning Management System

·Bachelors or equivalent degree, health related (e.g., Medical, Scientific, Nursing, Pharmacy) preferred

·At least 7 years of experience in the pharmaceutical industry, preferably in development operations/quality management

·Strong understanding of Quality by Design principles, clinical quality risk management processes, risk-based monitoring, and trial oversight as required by ICH E6 R2.

·English communication skill, TOEIC score of 850, or equivalent capability

·Broad knowledge of global process and Chinese local regulatory requirements related to clinical studies

·Ability to lead GCP inspection readiness activities and support global health authority inspections

·Strong knowledge management, project management and change management skills

·Strong data insights and analytical skills to identify trends and drive quality / process improvements.

·Leadership Behavior/Mindset

oNever satisfied with the status quo and always pursue improvements

oLook from the other person's point of view and address issues together

oCommunication skill to maintain a comfortable relationship with other functional areas and drive the business in collaboration

·China CSM

·China Development

·RDQA

·Clinical Process Excellence

·Clinical Process Compliance

·Process and Performance Learning