1. 质量体系建立与维护：负责公司无菌制剂（含多肽及小分子化药制剂）全生命周期质量管理体系的建立、实施与持续改进，确保符合中国NMPA、美国FDA、欧盟EMA等国际法规要求。 ​Quality System Development & Maintenance: Establish, implement, and continuously improve the quality management system for aseptic preparations (including peptide and small molecule drugs), ensuring compliance with NMPA, FDA, EMA, and other international regulations. ​2. 现场质量监控与合规管理：主导无菌制剂生产车间（原料药至制剂）的现场质量巡查、工艺监控及环境控制，确保GMP合规性，应对国内外官方审计及客户现场检查。 ​On-site Quality Control & Compliance: Lead GMP compliance inspections, process monitoring, and environmental controls in aseptic production facilities (from APIs to finished products), ensuring readiness for regulatory and client audits. ​3. 验证与确认管理：审核并批准无菌制剂相关设备、工艺、清洁验证/确认方案及报告（如培养基模拟灌装、隔离器系统验证），保障生产质量风险可控。 ​Validation & Qualification: Review and approve validation protocols/reports (e.g., media fill, isolator systems) for equipment, processes, and cleaning, ensuring risk-controlled production quality. ​4. 偏差与质量事件处理：主导重大偏差、OOS/OOT、变更、投诉等质量事件的调查与CAPA制定，确保根本原因分析及闭环管理。 ​Deviation & Quality Incident Management: Lead investigations and CAPA implementation for critical deviations, OOS/OOT, changes, and complaints, ensuring root cause analysis and closed-loop resolution. ​5. 文件与记录审核：审批无菌制剂生产批记录、质量标准、SOP等文件，监督电子数据完整性（如LIMS、MES系统），确保数据可靠性。 ​Document & Record Review: Approve batch records, specifications, SOPs, and oversee electronic data integrity (e.g., LIMS, MES systems) to ensure data reliability. ​6. 产品质量回顾与趋势分析：组织年度产品质量回顾（APR），分析生产数据趋势，推动质量目标达成与工艺优化。 ​Product Quality Review & Trend Analysis: Conduct Annual Product Reviews (APR), analyze production trends, and drive quality objectives and process optimization. ​7. 团队与跨部门协作：管理QA团队，协同研发、生产、供应链部门，确保中间体-原料药-制剂全产业链质量一致性。 ​Team & Cross-functional Collaboration: Manage QA teams and collaborate with R&D, production, and supply chain to ensure end-to-end quality consistency.

1. Undergraduate degree in pharmaceutical, biological, chemical sciences, orengineering 药学、生物学、化学科学或工程学相关本科学位。 2.Relevant advanced degree preferred 相关高级学位优先, 3.Supervisory experience 8 or more years 管理经验8年或8年以上。 4.Minimum of 10 years progressive experience in the technical, quality control,sterile preparations for human health products 至少10年在技术、质量保证、无菌制剂方面的经验。 5.Deep knowledge & experience of cGMP's & effective quality management anddemonstrated leadership of Regulatory Inspection Management and RegulatoryAffairs.对cGMP 有深入了解，有效的质量管理经验并在法规检查管理方面有丰富经验。 6.Deep knowledge / Expertise in Pharmaceutical/Bio-PharmaceuticalManufacturing Processes 丰富的药品/ 生物制药生产流程方面的专业知识 7. Fluent in English (written and spoken)有一定的英语水平(书面和口语)