Quality Assurance Lead for Active Pharmaceutical Ingredients (API) - Department Leadership: Oversee departmental activities to ensure quality compliance of active pharmaceutical ingredients (API) at key contractors in China. Provide quality support in GMP operational areas, including production and quality control. - Change Management: Manage change controls and production deviations while conducting investigations for Out of Specification (OOS) results, quality control deviations, and ensuring effective corrective and preventive actions are implemented for complaints, returns, and recalls. - Documentation Evaluation: Assess and evaluate manufacturing documentation, including manufacturing batch records, analytical documentation, process validation documents, method transfer documentation, QA agreements, and product quality reviews to ensure compliance and quality integrity. - GMP Auditing: Conduct GMP audits of API manufacturers and lead the preparation for regulatory inspections and audits, ensuring full compliance with industry standards and best practices. - Standard Operating Procedures (SOPs): Implement and maintain SOPs for Quality Assurance (QA) and Quality Control (QC), while regularly reporting quality indicators and performance metrics to management to drive continuous improvement.

(6 years 1 month) Quality Assurance Lead for Active Pharmaceutical Ingredients (API) - Department Leadership: Oversee departmental activities to ensure quality compliance of active pharmaceutical ingredients (API) at key contractors in China. Provide quality support in GMP operational areas, including production and quality control. - Change Management: Manage change controls and production deviations while conducting investigations for Out of Specification (OOS) results, quality control deviations, and ensuring effective corrective and preventive actions are implemented for complaints, returns, and recalls. - Documentation Evaluation: Assess and evaluate manufacturing documentation, including manufacturing batch records, analytical documentation, process validation documents, method transfer documentation, QA agreements, and product quality reviews to ensure compliance and quality integrity. - GMP Auditing: Conduct GMP audits of API manufacturers and lead the preparation for regulatory inspections and audits, ensuring full compliance with industry standards and best practices. - Standard Operating Procedures (SOPs): Implement and maintain SOPs for Quality Assurance (QA) and Quality Control (QC), while regularly reporting quality indicators and performance metrics to management to drive continuous improvement.

- Daily Operations Support: Assist in the department's daily activities by addressing user inquiries through Customer Relationship Management (CRM). Analyze daily and monthly CRM statistics, utilizing Tableau to visualize data and identify trends. - Feedback Improvement Project: Contribute to initiatives aimed at enhancing the efficiency of structured feedback processes and developing a feedback tool to streamline communication. - Quality Assurance Checks: Perform quality checks on user interactions to ensure adherence to quality standards and maintain a high level of service.

- Quality and Performance Support: Assist in quality and performance- related matters within the department, including reporting, revising, and updating departmental KPIs using Kibana. Present updates and action plans at management meetings and to the Corporate Governance Service, while strategically planning departmental objectives. - Audit Participation: Engage in both external and internal audits for ISO certifications (ISO 9001, ISO 10002, ISO 27001) by reviewing documentation and collaborating with the department's data protection coordinator to draft and finalize data protection notifications and privacy statements. - Project Management: Lead a project focused on analyzing trends in Chinese trademark applications, providing insights to support decision-making and strategic planning.

Laboratory Instruction: Organize and conduct laboratory exercises for undergraduate students in a biotechnology lab, facilitating hands-on learning experiences and promoting practical application of biotechnological principles.