General Mission职责概述 • Implement and monitor quality system for quality document/record management, Training management. Ensure quality system running effectively, compliance to CGMP and Sanofi global requirement. • 执行和监督质量体系的运行，负责质量文件、记录管理，确保质量体系被有效运行，符合现行GMP和赛诺菲总部要求。 Activities具体职责 Documentation System 文件体系管理 • Overseeing and managing the creation, revision, and obsolescence of all GxP documents. • 监督并管理所有 GxP 文档的创建、修订和作废。 • Collaborating with other departments to ensure documentation needs are met and processes are aligned. • 与其他部门合作，确保满足文档需求并且管理流程达成一致。 • Ensuring the documentation package is kept lean (i.e., avoiding redundancies and duplication) • 确保文档包保持精简（即避免冗余和重复） • Ensuring with the support of relevant experts that all documentation complies with regulatory and company requirements. • 在相关专家的支持下，确保所有文档都符合法规和公司要求。 • Reviewing and approving quality system documents to ensure harmonization, accuracy, completeness and compliance with writing rules and company strategies. • 审查和批准质量体系文件，以确保协调性、准确性、完整性并符合撰写原则和公司策略。 • Ensuring document distribution and access complies with the information classification level. • 确保文档分发和访问符合信息分类级别。 • Collecting needs for documentation changes, prioritizing and managing documents update. • 收集文档更改的需求，确定文档更新的优先级并管理 • Ensure the implementation of an efficient documentation process, in conformance with Global documentation strategies supporting simplification, harmonization and digitalization. Ensure local implementation of the necessary changes. • 确保实施高效的文档流程，符合支持简化、协调和数字化的全球文档战略。确保在本地实施必要的变更。 • Preparing documentation for internal, external audits and inspection, ensuring all required documents are up-to-date and accessible. • 为内部、外部审计和检查准备文件，确保所有必需的文件都是最新的和可访问的。 • Managing the documentation team and ensuring their proper qualification for their activities. • 管理文档团队并确保他们具备合适的资质，能够胜任其活动。 • Being representative of the site in the CoP documentation led by the global and if requested participating in the CoE and ensure local communication. • 代表杭州工厂参与Global领导的文档管理 CoP 会议，并应要求参与 CoE 并确保本地沟通。 • Global Document Gap Analysis • Global文件分析与执行 Training Management 培训管理 • Developing and implementing annual training programs to ensure compliance with Good Manufacturing Practices (GMP) and other regulatory standards. • 制定和实施年度培训计划，以确保符合良好生产规范 （GMP） 和其他监管标准。 • Collaborating with department heads to identify training needs and developing customized training plans. • 与部门负责人合作，确定培训需求并制定定制的培训计划。 • Supporting the managers in the establishment of the curricula for the different areas. • 支持管理人员为不同领域建立课程包. • Conducting training sessions for new hires and existing employees on specific topics. • 为新员工和现有员工举办特定主题的培训课程。 • Monitor the completion of the training plan to identify risks and weaknesses. • 监控培训计划的完成情况，以识别风险和薄弱点。 • Evaluating training effectiveness through assessments, feedback, and performance metrics. • 通过评估、反馈和绩效指标评估培训效果 • Updating training materials with the support of the relevant subject matter expert to reflect changes in regulations, procedures, and best practices. • 在相关主题专家的支持下更新培训材料，以反映法规、程序和最佳实践的变化。 • Leading continuous improvement initiatives to enhance training material and processes. • 领导持续改进计划，以改进培训材料和流程。 • Providing support during regulatory inspections and audits by presenting training records and training process and material. • 通过提供培训记录、培训流程和材料，在监管检查和审计期间提供支持。 • Managing the training team and ensuring their proper qualification for their activities. • 管理培训团队并确保他们具备合适的资质，能够胜任其活动。 • Being representative of the site in the CoP training led by the global and if requested participating in the CoE and ensure local communication. • 代表杭州工厂参与Global领导的培训管理 CoP 会议，并应要求参与 CoE 并确保本地沟通。 Quality Maturity Index 质量成熟度项目 • Quality Maturity Index: Responsible for regular communication and updates of the Quality Maturity Index (QMI). 质量成熟度：负责质量成熟度指数（QMI）的定期沟通和更新。 3rd party management第三方管理 • Establish supplier management procedures; manage supplier profiles; propose audit requirements and conduct audit assessments; draft quality agreements; conduct annual performance evaluations of approved suppliers; review material quality information. • 建立供应商管理程序；管理供应商档案；提出审计需求并进行审计评估；起草质量协议；对已批准的供应商进行年度绩效评估；审核物料质量信息。 • Communicate with supplier for the related material defect identified in the site manufacturing. Draft and coordinate the signature of quality agreement with suppliers. • 与集团内部工厂沟通生产过程中所识别的物料缺陷；起草并协调集团内部供应商质量协议的签订 • Maintenance of QSMP. Including drafting, updates, and archiving. • QSMP 维护（起草，更新，存档）. • Third Party Change Notification process management. • 供应商变更通知流程管理. • Third Party Complaint process management. • 供应商投诉管理. Registration dossier preparation and submission support注册资料的撰写与申报支持

Experience 经验 • 5 years of experience in quality management systems in the pharmaceutical industry. Including in the development, review, and approval of quality system documents. Ensuring compliance with GMP and other regulatory standards and experience in developing, implementing, and evaluating training programs, particularly those related to quality systems and regulatory compliance. And experience in 3rd party management. • 5 年制药行业质量管理体系经验。 包括质量体系文件的制定、审查和批准。确保遵守 GMP 和其他监管标准，并在制定、实施和评估培训计划方面拥有丰富的经验，尤其是与质量体系和法规合规性相关的培训计划。以及第三方管理工作经验。 Skills 技能 • Ability to analyze complex data, identify trends, and make data-driven decisions to improve quality and compliance. 能够分析复杂数据、识别趋势并做出数据驱动的决策以提高质量和合规性。 • Excellent problem-solving abilities to address and resolve quality issues, including root cause analysis and implementation of corrective actions. 出色的问题解决能力，能够解决质量问题，包括根本原因分析和纠正措施的实施。 • Strong project management skills to oversee multiple quality initiatives, manage timelines, resources and ensure successful completion of projects. Present project outcomes to senior management. 强大的项目管理技能，能够监督多项质量计划，管理时间表，资源并确保成功完成项目。向高级管理层展示项目成果。 • Ability to meticulously review and manage documents to ensure accuracy, completeness, and compliance with regulatory standards. 能够仔细审查和管理文档，以确保准确性、完整性并符合监管标准。 • Proficiency in using electronic document management systems and other relevant software tools for document control and management. 熟练使用电子文档管理系统和其他相关软件工具进行文档控制和管理。 • Ability to create effective training programs and materials that meet the needs of the organization and comply with regulatory standards. 能够创建满足组织需求并符合监管标准的有效培训计划和材料。 • Proficiency in evaluating training effectiveness through data analysis, assessments, and feedback to continuously improve training programs. 熟练通过数据分析、评估和反馈来评估培训效果，以不断改进培训计划。 • Strong understanding of regulatory requirements and the ability to ensure training programs align with these standards. 对法规要求有深刻的理解，并能够确保培训计划符合这些标准。 • Expertise in planning, organizing, and managing training projects, including setting timelines, allocating resources, and monitoring progress. 规划、组织和管理培训项目的专业知识，包括设定时间表、分配资源和监控进度。