招聘｜QA Manager/Senior QA Manager

工作地点：杭州

汇报对象：CMC负责人

• Note: This job position will be fully supported by quality consultancy. 注：本职位将由质量服务顾问提供全面支持。

Key Activities主要工作内容：

• According to Inmagene research and development plan, communicate with domestic and oversea CDMO. 根据公司研发计划，与国内和海外CDMO机构进行沟通，以满足业务目标。

• Draft and sign off quality agreement with key vendors. 负责与主要供应商起草并签署质量协议。

• Responsible for establishing the company’s quality management system according to relevant domestic and foreign industry regulations, which meets the management requirements of each department. 负责按照国内外相关行业规定建立符合各部门管理要求的公司质量管理体系。持续跟踪国内外GMP及相关药事法规变化，组织好GMP培训工作。

• Responsible for organizing the compilation, review and distribution of all quality system documents, as well as the upgrading and revision. 负责公司质量体系的建立，组织所有质量体系文件的编制、审核和分发，并负责升级和修订。

• Responsible for leading and organizing the training and assessment of all quality personnel to ensure the smooth operation of the quality management system in accordance with regulations. 负责领导和组织对所有质量人员的培训和考核，确保质量管理体系按规定顺利运行。

• Responsible for organizing and carrying out the annual internal audit and management review of the quality department of the company and the subsidiary, identifying the nonconformance, and tracking the rectification of the nonconformance. 负责组织开展公司及子公司质量部年度内部审核和管理评审，识别不符合项，跟踪不符合项的整改情况。

Knowledge/Experience 知识/经验

• B.E. or B.S. degree (preferably in biology or pharmaceutical) with at least 6 years of experience in the pharmaceutical or biopharmaceutical industry, or an equivalent combination of education and experience.本科学位（生物学或药学优先），在制药或生物制药行业至少有6年的经验，或具有同等的教育和经验组合。

Work Skills 工作技能

• Working knowledge of cGMP, Guidelines and standards routinely used in the industry. 熟悉cGMP的工作知识，行业中常用的指南和标准。

• Ability to interpret and follow Quality standards. 理解和遵循质量要求。

• Strong interpersonal skills which include a professional demeanor when interacting with personnel at all levels within operations, suppliers, contract manufacturers, regulatory agency representatives, etc. 较强的人际交往能力，包括与运营部门、供应商、合同制造商、监管机构代表等的各级人员互动时的职业风范。

• Flexibility in problem solving and work hours to meet business objectives.在解决问题和工作时间方面具有灵活性，以满足业务目标。

• Requires excellent verbal English.优秀的英语口语沟通能力。

联系人：Will

简历投递：HR@drugtimes.cn

友情提醒：请在邮件主题栏中注明“QA Manager/Senior QA Manager”