About this role
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 qualityDevelop, maintain, and oversee the quality system and associated strategy, processes, tools, and technologiesPerform local business process management in alignment with global/local regulatory requirementsLead impact assessment (IA) discussions around new/updated local regulations as well as Global QSDs in collaboration with the IA team membersIdentify 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 applicableIn consultation with China R&D leadership, review and refine training curriculum for local roles in the Learning Management SystemProvide advice to China R&D including global/local clinical processes, procedural documents and on international guidelines such as ICH-GCP, industry standards and local regulationsExplore more efficient ways in improvement of quality and implement that in collaboration with stakeholders through process management, training and other quality activitiesLead audit response management and review quality issues and audit/inspection CAPAs to ensure suitability Bachelors or equivalent degree, health related (e.g., Medical, Scientific, Nursing, Pharmacy) preferredAt least 7 years of experience in the pharmaceutical industry, preferably in development operations/quality managementDemonstrate leadership and promote projects by inspiring and involving the stakeholdersStrong understanding of Quality by Design principles, clinical quality risk management processes, risk-based monitoring, and trial oversight as required by ICH E6 R3English communication skill, TOEIC score of 850, or equivalent capabilityBroad knowledge of global process and Chinese local regulatory requirements related to clinical studiesAbility to lead GCP inspection readiness activities and support global health authority inspectionsStrong knowledge management, project management and change management skillsStrong data insights and analytical skills to identify trends and drive quality / process improvementsLeadership Behavior/MindsetNever satisfied with the status quo and always pursue improvementsLook from the other person's point of view and address issues togetherCommunication skill to maintain a comfortable relationship with other functional areas and drive the business in collaboratio
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