Quality Management System Development and Operations: Oversee the establishment and optimization of the group headquarters' biopharmaceutical全产业链 quality management system, covering R&D, production, release, storage, and supply chain processes. Align with global regulatory requirements including China GMP, FDA, and EU EMA to ensure compliance and stable system operation.

 · Lead FDA and EU EMA registration/certification, on-site inspections, and annual audits for biopharmaceutical products. Coordinate responses to domestic/international regulatory bodies, clients, and third-party audits, addressing audit deficiencies and closing corrective actions to ensure certification success.

 · Develop quality control standards, deviation management, change control, and CAPA processes. Identify quality risks across production and R&D workflows, lead major quality incident investigations, and strictly control product quality risks.

 · Build a quality-specialized team, establish departmental management systems, work protocols, and performance evaluation frameworks. Oversee daily operations, personnel development, and task allocation in the Quality Department to enhance professional capabilities and operational efficiency.

 · Continuously monitor updates in domestic/international biopharmaceutical regulations and industry standards. Optimize quality management systems in alignment with corporate business evolution. Strengthen documentation management to ensure data integrity, authenticity, and traceability.

 · Cross-departmental collaboration: Coordinate with R&D, production, registration, supply chain, and marketing departments to implement quality compliance. Optimize manufacturing processes and quality control workflows, supporting product commercialization and large-scale production.