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Insulin QC Manager
4 months ago
Are you motivated by driving innovation for the life-changing benefit of patients? Are you ready to help transform the treatment paradigm for a broad range of chronic diseases that currently rely on injection-based therapies? Then this is your moment. Apply now and join Novo Nordisk. Together we can create life-changing innovation. Together we can make it happen.
The position
Delivery of business result
Ensure stable operation for QC labs to support AP/FP/DD production保证 QC 实验室的稳定工作来支持 AP/FP/DD 的生产 Ensuring delivery of test results and other laboratory services in accordance with customer and business requirements and targets
保证实验室按照客户和商业的要求和目标提供服务 Ensuring both drug and device QC lab personnel are appropriately trained to perform job tasks
保证药品和器械测试 QC 人员有合适的培训以完成工作 Ensuring safe working environment and compliance with internal and external EHS requirements
保证安全的工作环境以符合内外部 EHS 的要求 Ensuring development and implementation of SOPs and instructions governing all aspects of laboratory services
保证实验室的 SOP 和指导文件的发展和全面执行 Developing efficient processes for running day-to-day operations in the laboratory
优化实验室日常操作的效率 Driving continuous improvement through use of cLEAN leadership principles and tools
使用 cLEAN 原理和工具以持续发展 Communicating with other Novo Nordisk sites to share best practices, transfer knowledge, and coordinate support.
与其他诺和诺德生产厂分享好的经验，分享知识和互相支持 Strong leadership being able to develop the organization and proven success in developing talents. Act as mentor for colleagues within field of expertise.
拥有很强的领导力，能够识别并发展潜力员工，规划组织发展，并能作为工厂内有潜力发展的员工的导师
Compliance and quality mindset 合规和质量意识
Working closely with QA to ensure laboratory work is in compliance with NN requirements, Chinese local and national regulations as well as GMP requirements.与 QA 紧密合作以保证实验室工作符合 NN ，本地和国家法规要求，同时也需符合 GMP 的要求 Handling authority audits and other regulatory affairs issues related to the lab
处理与实验室相关的政府审计和其他法规事务 Ensuring OOS results and incidents (i.e. DVs) are investigated corrective and preventative actions are implemented as needed
保证 OOS 结果和事件（如 DV ）被正确调查，合理的纠正和预防措施被执行 Planning and coordinating support from other departments inside and outside of STJ
计划和协调支持天津工厂内外部的其他部门 Monitoring and approving work performed by outside contract labs
监控和批准外部合同实验室的工作 Communicating with customers and stakeholders
与客户和利益相关方的良好沟通 Ensuring GMP compliance and inspection readiness at all times
总是保证 GMP 的合规度和迎审状态 Ensuring accurate and timely documentation of all work in accordance with GMP, site, and corporate procedures and policies
保证按照 GMP 、工厂和公司文件政策真实且及时地记录工作
People management 人员管理
Managing employee performance, including goal-setting, performance evaluation, and on-going performance feedback管理人员绩效，包括目标设定，绩效审核和及时的绩效反馈 Coaching and developing QC leaders to reach their full potential
指导和发展 QC 副经理及主管以发挥其最大潜力 Cultivate cLEAN mindset and compliance culture in own department
在本部门提高 cLEAN 意识和合规文化 Establishing and training employees to have a customer service mindset where the customer is at the centre of services provided
建立和培训员工有为客户服务的意识，以客户为中心 Ensure education, training and motivation of employees and through this best possible utilization of the departments’ resources
保证教育、培训和鼓励员工，并保证部门资源的使用最佳化 Manage the area according to Novo Nordisk Way and thereby ensure good results in Evolve and facilitation.
按照诺和诺德之道管理部门并保证 Evolve 和鉴导的良好结果
Finance responsible 财务职责
Ensure budget plan and make good control according to approval保证预算计划被批准并有良好控制
EHS responsible EHS 职责
Ensure that Novo Nordisk policies regarding environment and working safety and other relevant law requirements are met.保证环境和工作安全对诺和诺德政策和其他法规要求的符合性 Ensure the department’s environmental, health and safety work is organised, managed and executed in accordance with this manual. Detailed description is provided in enclosure 2 of EHS manual (QBIQ doc. No. 044249)
保证按照手册 - 详细描述见附件 2EHS 手册（ QBIQ doc. No. 044249 ）组织、管理和执行部门环境、健康和安全工作
Qualifications
Bachelor degree or above majored in Chemistry, Pharmacy, Engineering or other scientific or technical field化学，药剂学，工程学或其他相关领域 4 年本科教育学士及以上学位 Fluent in written and spoken English
良好的英语书写和沟通能力 Minimum 8 years quality- or production-related experience in the pharmaceutical industry working in a GMP-regulated environment
至少有 8 年在 GMP 制药企业质量或生产的经验 Previous pharmaceutical QC lab experience, including responsibility for lab operations, analysis, method validation/transfer, and/or equipment qualification, highly desirable
具有药厂 QC 实验室经验，包括实验操作，分析，方法验证 / 转移，和 / 或仪器验证的经验 Previous line manager or project management experience highly desirable
具有管理岗或项目经理的经验 Previous experience with international ， pharmaceutical company and/or working abroad desirable
具有国际制药公司或海外工作经验 Previous experience using LEAN/cLEAN leadership tools and principles desirable
具有运用精益管理工具和原理的经验
