QA Manager

Job Description

Job Description 岗位职责说明 Department 部门： Medical Office, Research and Development医学办公室，研发部

Title 职位： Senior QA Manager 质量保证高级经理

Direct Report 直线经理： Quality Assurance Officer 质量保证负责人

Direct Subordinates 直接下属： None 无

Primary Function 主要职能：

The Senior QA Manager supports the I-Mab R&D QA organization through the conduct of audits to assess compliance with GLP (Good Laboratory Practice), GCP (Good Clinical Practice), GVP (Good Pharmacovigilance Practice), country specific regulations, and I-Mab Policies and Procedures. The Senior QA Manager is an experienced auditor who will be able to lead at least one audit type in one of the GXP area (investigational site audit is preferred). In addition, the Senior QA Manager will contribute to the execution of the I-Mab R&D QA strategy, development of R&D QA processes and procedures, participate in R&D QA goals and initiatives in line with the QMS implementation, and support regulatory authority inspections. 质量保证高级经理通过审计评估天境生物研发工作是否符合GLP,GCP,GVP的要求，符合地方性法律法规和天境生物内部政策和文件的规定。 质量保证高级经理作为稽查员可以领导至少一种GXP领域的稽查活动(首选是研究中心稽查)。质量保证高级经理将协助执行天境生物研发质量保证政策，制定质量保证流程和文件，参与研发质量保证的目标和实施符合质量管理体系，并支持监管机构的视察。

Major Responsibilities and Duties 主要职责和任务:

• Delivery of the R&D QA Audit Program 研发部质量保证稽查项目的交付
• Perform and lead audit activities including audit preparation, conduct, presentation, timely reporting of audit findings, and evaluation of CAPAs 领导和执行稽查活动，包括稽查的准备，实施，展示，及时汇报稽查结果以及评估CAPA
• Group individual audit issues into systematic issues and areas of opportunity for process improvement beyond the individual audit findings 汇总独立稽查问题使之成为稽查系统，并提供整体改进措施。

• Present observations and associated compliance risks to auditees and I-Mab internal/external stakeholders and prepare a written audit report. 被稽查单位和天境生物内部/外部利益相关者汇报稽查结果及相应的合规风险，准备书面稽查报告。
• Ensure appropriate Corrective and Preventative actions (CAPA) have been developed by the auditees and determine acceptability of evidence for CAPA implementation 确保被稽查单位制定了合适的纠正预防措施(CAPA)，判断CAPA实施的合理性

• Participate in post-audit meetings to discuss unresolved issues with Senior Management 参加稽查后会议，与高级管理层讨论未解决问题

• Execution of the R&D QA Strategy 研发部质量保证政策的执行
• Involve in GXP vendor qualification and vendor management activities 参与GXP供应商资质和供应商管理活动

• Provide education and/or training to GXP functional areas and non-clinical/clinical study teams 为GXP功能部门以及非临床/临床研究团队提供相关教育和/或培训

• Support the preparation for and conduct of regulatory authority inspections 协助准备管理当局的视察

• Contribute to the development and/or revision of R&D QA processes and procedures including SOPs, Work Instructions, and auditor tools 研发质量管理程序和文件的制定和/或修订，包括SOP，工作手册和稽查工具

• Support in generation of quality metrics 协助质量衡量指标的制定

• Develop and maintain a knowledge of company policies, SOPs, and supporting documents related to drug development as well as FDA and EU regulations and ICH guidance documents (as applicable) along with any other national or international regulations that may affect drug development and post-marketing processes (as applicable) 熟知与药物开发有关的公司政策，SOP，支撑文件，FDA和欧盟法规，ICH指导文件(如适用)，以及其他可能会影响药物开发和上市后流程的国家或国际法规(如适用)

• Group individual audit issues into systematic issues and areas of opportunity for process improvement beyond the individual audit findings 汇总独立稽查问题使之成为稽查系统，并提供整体改进措施。

• Present observations and associated compliance risks to auditees and I-Mab internal/external stakeholders and prepare a written audit report. 向被稽查单位和天境生物内部/外部利益相关者汇报稽查结果及相应的合规风险，准备书面稽查报告

• Ensure appropriate Corrective and Preventative actions (CAPA) have been developed by the auditees and determine acceptability of evidence for CAPA implementation 确保被稽查单位制定了合适的纠正预防措施(CAPA)，判断CAPA实施的合理性

• Participate in post-audit meetings to discuss unresolved issues with Senior Management 参加稽查后会议，与高级管理层讨论未解决问题

• Perform other tasks as assigned by line management in line with the Senior QA Manager’s duties 其他直线经理分配的与质量保证高级经理职责相关的任务

Qualifications 资格要求:

• Bachelor's degree or equivalent in scientific or quality-related field or equivalent combination of education, training, and experience 大学本科，或在科学，质量相关领域具有同等程度的教育，培训和经验

• Minimum 6 years in pharmaceutical industry and/or non-clinical/clinical research experience 至少五年药企工作经验和/或非临床的GLP/GCLP环境工作经验

• Minimum 3 years in GLP/GCP/GVP Quality Assurance role. 至少两年GLP/GCP/GVP质量保证员经验

• Experience and competency in conducting several audit types and leading at least one audit type within one GXP area 具有执行不同类型稽查的经验和能力，至少可以领导一种GXP范围内的稽查

• Knowledge of drug development processes and GXP regulations 熟知药物发展过程和GXP管理规定
• Ability to influence and negotiate effective solutions within audit teams and internal/external stakeholders

能够在审计团队内部或与外部/内部的利益相关者在影响并协商有效解决方案

• Demonstrated ability to work both independently and in a team environment 具备独立工作和团队协作能力

• Demonstrated analytical, problem-solving and decision-making skills 具备分析能力，问题解决能力和决策能力

• Strong verbal and written communication and customer management skills 出色的口头和书面表达能力与客户管理能力
• Demonstrated ability to effectively organize and execute tasks 具备有效组织能力和执行力

• Computer proficiency 熟练使用电脑
• Fluency in written and spoken English required 出色的英语口头和书写能力