质量控制项目经理

85 Responsible for drafting, reviewing, and implementing QC-related quality standards, methods, COA templates, and related technical documents .

负责起草、审核和实施QC相关的质量标准、方法、COA模板及相关技术文件Manage the preparation, review, and finalization of product COAs in compliance with GMP and regulatory requirements.

管理COA的撰写、审核和定稿，确保符合GMP及法规要求。

85 Design, review, and manage stability study protocols and reports, ensuring compliance with ICH and regulatory expectations.

设计、审核并管理稳定性研究方案和报告，确保符合ICH及法规要求。

85 Support and coordinate QC activities related to regulatory filings (e.g., IND/BLA/NDA) and provide project-specific technical input.

支持和协调与注册申报（如IND/BLA/NDA）相关的QC活动，并提供项目相关的技术支持。

85 Collaborate with cross-functional teams (QA, RA, Process Development, Analytical Development, Manufacturing) to ensure seamless project execution.

促进跨部门（QA、注册、工艺开发、分析开发、生产）的合作，确保项目顺利执行；

85 Participate in and support project-related audits (internal, client, regulatory), prepare audit responses, and drive continuous improvement.

参与并支持项目相关的审计（内部、客户、监管），准备审计应对，并推动持续改进；