职位编号Job Code: QL03001
职位 Position: Associate Director of Clinical QA
部门 Department：Quality Assurance and Regulatory Affairs
汇报关系 Reports to: Director, Quality Assurance and Regulatory Affairs
办公地点 Location: Taicang Office or Remotely work in China

职位目标 Purpose or Objective of Position:

负责公司质量管理体系（QMS）的临床试验质量管理规范（GCP）部分的管理和运行，包括流程和合规性，并根据公司的SOP和GCP，通过稽查监督临床研究的质量。

This role is administratively and operationally responsible for Good Clinical Practice (GCP) portion of the company’s Quality Management System (QMS), including processes and compliance, oversight quality of clinical studies through audit, according to the company’s SOP and GCP.

主要职责 Key Responsibilities：

• 根据公司政策和GCP等要求，制定、更新和维护公司相关的制度和指南文件。Develop, renew and maintain company related systems and guidance documents in accordance with company policies and GCP requirements etc..
• 建立和管理公司GCP部分质量管理体系。Establish and manage Good Clinical Practice (GCP) portion of the company’s Quality Management System (QMS).
• 负责现场/远程稽查活动，按要求评估研究中心和CRO或供应商的表现，并协助维护研究中心关系。Responsible for on-site/ remote quality oversight visits to assess site and CRO or company monitoring performance as required, and support maintenance of site relationships at the site of the study.
• 与临床试验项目经理合作，监督CRO和研究中心的研究开展，确保符合试验方案、GCP、SOP等的要求。Collaborate with clinical trial project managers to oversee trial activities at CROs and clinical trial sites to ensure compliance with trial protocols, GCP, SOP etc. requirements.
• 建立内部质量稽查计划，按照质量稽查计划的要求，完成对内质量稽查工作。Establish an internal quality audit plan and complete internal quality audits in accordance with the requirements of the quality audit plan.
• 建立外部质量稽查计划，按照质量稽查计划的要求，完成对研究中心、CRO及供应商的质量稽查工作。Establish an external quality audit plan and complete quality audits of clinical trial sites, CRO and  in accordance with the requirements of the quality audit plan.
• 负责对临床稽查的问题提出可行性建议及稽查报告、CAPA撰写或审核，并跟踪问题解决情况，对稽查发现进行阶段性总结并组织培训。Responsible for making feasible suggestions and writing or review audit reports, CAPA on the problems of clinical audits, and following up on problem solving, conducting stage summaries of audit findings and organizing training.
• 为相关部门员工提供相关的SOP或GCP培训、项目稽查总结培训等。Provide relevant SOP or GCP training, audit findings summary training etc. to relevant department staff.
• 对临床试验供应商进行审计和日常监督。Audit and daily monitoring of clinical trial suppliers.
• 负责药监部门检查接待及内外部协调，指导并审阅检查缺陷项的回复，制定CAPA，培训并监督执行，对CAPA进行跟踪。Responsible for drug regulatory department inspection reception and related coordination, guidance and review of inspection deficiency item response, development of CAPA, training and supervision of implementation, and follow-up of CAPA.
• 上级主管交办的其他事项。Other matters assigned by LM.

职位要求Job Requirements:

Education:

• Bachelor’s degree and Above – Biopharmaceutical related major
• GCP training certificate

 Experience:

• 具备丰富的临床稽查经验，对临床运营有全面了解。熟悉各种临床研究，有广泛治疗领域临床试验管理经验。充分了解ICH-GCP、中国GCP、临床试验行业法规要求。Extensive experience in clinical auditing and a thorough understanding of clinical operations. Familiar with various clinical studies and clinical trial management experience. Extensive knowledge of ICH-GCP, China GCP guidelines and clinical trial industry regulatory requirements
• 流利的英文和中文书面和口头交流Fluent English and Chinese in written and oral communication.
• Skilled in Office software.