Job Purpose工作目的
Lead GZ site quality digital transformation to improve efficiency and compliance
领导广州工厂的质量数字化转型，提高效率和合规性
Ensure the data integrity of all IT system and e-compliance in the whole GZ site02
确保所有IT系统的数据完整性和整个工厂的电子合规性
Main responsibilities主要职责
In support of site quality head for developing digital strategy and design a phased delivery plan, lead on time 02delivery of the program on behalf of quality organization by project managing all aspects of the strategy and delivery plan, developing solutions and other automated processes, liaising with all key internal and external stakeholders and provide regular reporting on progress.02
支持工厂质量领导去制定数字化战略，能设计阶段***付计划;代表质量组织项目按时交付，管理战略和交付计划的所有方面，开发解决方案和其他自动化过程，与所有关键的内部和外部利益相关者保持联系，并定期报告进展情况
Work with Global QA and IT to ensure the globalized quality IT system is implemented in GZ site on time02
和全球QA和IT一起确保全球化的质量IT系统在广州工厂实施。
lead digital & automation systems validation activities based on risk and compliance management, provide quality oversight, review and approve digital system related URS, qualification/validation and CSV related deliverables.02
基于风险分析及系统合规管理，统筹工厂数字化自动化系统的计算机验证管理，提供质量监督，审核和批准数字系统相关URS，确认/验证和CSV相关交付物
Ensure GMP computerized system data integrity and e-compliance
确保GMP计算机化系统的数据完整性和电子合规性
Work with other operational functions on quality and compliance optimization based on the digital and automated solutions,02
基于数字化和自动化的解决方案，优化现有的质量和合规流程。
Drive and execute the automated QC initiatives, like auto sample delivery system, robotic lab execution (ELISA station, Bioburden robot etc.)
驱动和执行自动化QC的项目，比如自动样品分配系统，实验室机器人执行系统（ELISA工作站，生物负荷的自动测试）
Support China quality digitalization.
支持中国质量的数字化项目
Any other assignment as is determined by supervisor.
完成上级安排的其他工作。
02

Education/ Professional Qualification
学历/专业资格
610202 02Pharmaceutical, Biology, Information Technology, IT, automation, engineering or related field;
药学、生物、信息工程，IT，自动化，工程或相关领域;
610202 02At least 8 years relevant experience with College degree or above, or 02at least 5 years relevant experience with Mater degree, or 02at least 3 years relevant experience with Doctoral degree;
大专及以上学历，至少8年工作经验;或硕士学历，至少5年工作经验;或博士学历，至少3年工作经验;
610202 02At least 3 years team management experience;
至少3年团队管理经验;
Technical/Skills Required
技术/技能需求
Deep understanding and experienced CSV management,
对计算机化系统验的管理证有深刻的理解和经验;
Strong knowledge on QA or QC of Pharmaceutical industry;
扎实的制药企业QA,QC知识;
Deep understanding and experienced on GAMP5, 21CFR Part 11, and related cGMP requirements;02
对GAMP5、21CFR Part 11和 cGMP相关的法规有深入理解和经验;
Strongly adaptability to new knowledge, ideas, and transformation; Familiar with multiple tools to search the latest academic, industrial, and regulatory trends, literatures, and reports; Sense of rapid study;
具有对新知识、新概念和转型变革的强大适应力;熟悉运用搜索学术、产业、法规等领域最新趋势、文献、报告的各类工具; 快速学习的能力;
Ability to identify and resolves complex or diverse information in a systematic methodology; Gathers and analyzes information using the appropriate tools and resource; Apply induction and deduction on daily projects and issues. Capable to analyze and visualize complex processes and present to stakeholders;
有能力识别复杂或多样化问题并用系统的方法论解决问题;采用合适的工具和资源去搜集和分析信息; 善于运用归纳法和演绎法处理日常项目和问题; 有能力梳理并可视化复杂的流程;
Lead cross-functions or cross-sites for quality management continuous improvement;
带领跨部门或跨公司的团队进行质量管理的持续改进;
Strong knowledge on project management including resources control, risk and change control, stakeholders’ management, and project summary;
具有扎实的项目管理知识，包括资源、风险和变更控制，利益相关者管理以及项目总结;
Teamwork spirit, can guide team and lead them via correct direction for work;
团队合作精神,能引领并指导团队在正确的方向进行工作;
Working Experience
工作经验02
8 years working experience in pharmaceutical industry, including but not limited to SAP/MES/LIMS/EMS, etc;
医药行业8年以上信息化项目管理经验，包括不限于SAP、MES、LIMS、EMS等项目运行经验;
5 years working experience in QA or QC of pharmaceutical industry;
具有5年以上药企QA或QC的工作经验;
3 year experience in project team management;
具有3年以上项目团队管理经验;
Experience with a digital transformation in related industry is a plus;
有相关产业数字化转型经验者优先;
Experience with CSV quality system establishment/risk management and compliance lead is a plus;
有相关CSV质量体系建立/风险管理和合规主导经验者优先;
Language, Computer Literacy, Office Software, etc.
语言能力，电脑知识，办公软件等
Fluent with English and Chinese in both oral and written communication;
具有流利的英语和中文口语和书面沟通能力;
Strong computer science and technology knowledge is a plus;
具有较强的计算机科学和知识者优先;
Familiar with Microsoft Office software and common statistical software (e.g.Minitab, JMP);
熟悉微软办公软件和常见的统计软件（如Minitab, JMP）;

百济神州全球胜任力
当我们通过以下十二项全球胜任力，展现出 "患者为先"、"无界协作"、"锐意创新 "和 "追求卓越 "的价值观时，我们就能帮助全世界更多患者获得更多负担得起的药品。
●团队协作
●提供并征求坦诚及可行的反馈
●自我认知
●兼容并蓄
●积极主动
●开拓精神
●持续学习
●拥抱变化
●结果导向
●分析性思维/数据分析
●卓越财务
●清晰沟通
BeiGene Global Competencies
When we exhibit our values of Patients ***, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
●Fosters Teamwork
●Provides and Solicits Honest and Actionable Feedback
●Self-Awareness
●Acts Inclusively
●Demonstrates Initiative
●Entrepreneurial Mindset
●Continuous Learning
●Embraces Change
●Results-Oriented
●Analytical Thinking/Data Analysis
●Financial Excellence
●Communicates with Clarity
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