岗位职责：
Job responsibilities:
作为现场质量负责人，全面负责公司质量管理的运行
As the person in charge of site‘s quality, this position is fully responsible for the operation of the company's quality management.
1. 质量体系管理:
Quality system management
(1) 维护公司质量管理体系文件，确保所有体系文件的有效性
Maintain the company's quality management system documents and ensure the validity of all documents
(2) 负责质量相关的SOP起草，包括质量手册、程序文件、标准操作规程等。
Be responsible for the drafting of quality-related SOPs, including quality manuals, procedure documents, standard operating procedures, etc.
(3) 组织实施内部质量审核，对审核中发现的问题进行跟踪整改，确保质量体系的有效运行。
Organize and implement internal quality audits, track and rectify the problems found in the audits, and ensure the effective operation of the quality system.
(4) 组织管理评审，提供给公司管理层质量体系运行情况的分析报告和改进建议。
Organize management review, and provide analysis reports and improvement suggestions for the operation of the company's management quality system
2. 质量控制与监督
Quality Control and supervision
(1) 制定质量控制计划和标准，监督临床药品供应链各环节的质量控制执行情况。
Formulate quality control plans and standards, and supervise the implementation of quality control in all aspects of the clinical drug supply chain.
(2) 负责产品的检验、测试和放行工作，确保产品符合质量标准。
Be responsible for product inspection, testing and release to ensure that products meet quality standards.
(3) 对质量问题进行调查分析，提出纠正和预防措施，并跟踪措施的执行效果。
Investigate and analyze quality problems, propose corrective and preventive measures, and track the implementation effect of measures.
3. 客户质量审计管理：
Customer quality audit management
(1) 负责客户质量审计的组织、陪同
Be responsible for the organization and accompaniment of customer quality audits
(2) 负责客户质量审计发现项的整改落实
Be responsible for the CAPA implementation of the items found in the customer's quality audit.
4. 质量事故处理
Quality accident handling
(1) 负责质量事故的调查，并完成调查报告
Be responsible for the investigation of quality accidents and complete the investigation report
(2) 负责质量事故相关的整改方案的落实
Be responsible for the CAPA implementation related to quality accidents
5. 供应商管理
Supplier management
(1) 建立供应商评估体系，对供应商进行资质审核和现场审计。
Establish a supplier evaluation system and conduct qualification audits and on-site audits for suppliers
(2) 与供应商沟通质量问题，督促供应商改进产品质量和服务水平。
Communicate with suppliers about quality issues, and urge suppliers to improve product quality and service levels.
(3) 定期评估供应商绩效，为质量技术副总提供供应商管理决策依据。
Regularly evaluate supplier performance and provide supplier management decision-making basis for the vice president of quality and technology.
6. 法规合规与风险管理
Regulatory Compliance and Risk Management
(1) 跟踪国家和行业质量法规、标准的变化，确保公司质量管理体系符合相关要求。
Track the changes of national and industry quality regulations and standards to ensure that the company's quality management system meets the relevant requirements.
(2) 负责质量风险管理工作，识别、评估质量风险，提供风险控制建议。
Be responsible for quality risk management, identify and evaluate quality risks, and provide risk control suggestions.
(3) 处理质量投诉和不良事件，及时向质量技术副总汇报事件处理进展。
Handle quality complaints and adverse events, and report the progress of incident handling to the vice president of quality and technology in a timely manner.
7. 团队管理与培训
Team management and training
(1) 领导质量团队完成各项质量工作任务，对团队成员进行绩效评估和激励。
Lead the quality team to complete various quality tasks, evaluate and motivate team members.
(2) 制定质量培训计划，组织开展质量培训活动，提高团队成员的质量意识和专业技能。
Formulate quality training plans, organize and carry out quality training activities, and improve the quality awareness and professional skills of team members.
(3) 向上级汇报团队工作情况和人员发展需求。
Report the work of the team and personnel development needs to the superior
8. 沟通与协调
Communication and coordination
(1) 定期向上级汇报质量管理工作进展和问题，听取领导指示并落实。
Regularly report the progress and problems of quality management to superiors, listen to the instructions of leaders and implement them.
(2) 与公司内部各部门进行沟通协调，解决质量相关问题，促进跨部门合作。
Communicate and coordinate with various departments within the company to solve quality-related problems and promote cross-departmental cooperation.
(3) 与外部监管机构、客户和供应商保持良好沟通，维护公司质量形象。
Maintain good communication with external regulators, customers and suppliers to maintain the company's quality image.
岗位要求：
Job Requirements:
1. 拥有药学、医学、生物学等相关专业本科及以上学历，熟悉药品质量管理体系和相关法规、标准，具备扎实的质量专业知识。
Have bachelor degree or above in pharmacy, medicine, biology and other related majors, familiar with drug quality management system and related regulations and standards, with solid quality professional knowledge.
2. 5 年以上临床药品供应链质量管理工作经验，有质量团队管理和 GMP、GSP 等认证经验者优先。
Have more than 5 years of experience in quality management of clinical drug supply chain, experience in quality team management and GMP, GSP and other certifications is preferred.
3. 具备良好的分析和解决问题的能力、沟通和协调能力，熟练使用办公软件和质量管理软件，能独立处理质量问题并与不同部门及外部单位有效沟通合作。
Have good analytical and problem-solving skills, communication and coordination skills, proficient in the use of office software and quality management software, able to deal with quality problems independently and effectively communicate and cooperate with different departments and external units.
4. 高度责任心和敬业精神，坚持原则敢于担当，良好学习和创新精神，对质量工作认真负责，能不断提升自身专业素质和管理水平
Have high sense of responsibility and professionalism, adhere to the principle of daring to take responsibility, good learning and innovation spirit, serious and responsible for quality work, and be able to continuously improve their professional quality and management level
5. 有药品企业质量负责人和医疗器械质量负责人经验优先
Experience in the person in charge of quality in pharmaceutical companies and medical device quality is preferred
6. 英语读写熟练
Proficiency in reading and writing English
7. 熟练使用办公软件；
Be proficient in the use of office software.