岗位职责；

Lead product QC operation management and keep compliance;

负责产品QC运营管理和保持合规；

Lead QC audit preparation, handling audit and lead audit response

负责QC审计准备、迎审和领导审计回复；

Lead Product QC resource planning, budget and people management;

负责产品QC资源计划、预算管理和人员管理；

Lead QC OOX, deviation, abnorvent investigation and impact assessment;

负责QC超标/超趋势、偏差和实验室异常事件的调查和影响评估；

Proactively interact and communicate with cross functional teams in and out of QC to accurately deliver the information and collect the feedback on the QC operation in time;

积极与QC内外的跨部门进行交流和沟通，及时为QC的运作传达准确的信息以及搜集相关的反馈；

支持和协助QC负责人对QC部门进行管理；

Lead product QC team to keep data integrity, train and coach direct reports;

负责QC团队保持数据完整性，培训和引导团队成员；

Support and assist QC head on QC department management;

支持和协助QC负责人对QC部门进行管理；

Complete other work items arranged by leaders.

完成上级领导安排的其他工作任务。

Bachelor （Master or above degree preferred） in Pharmacy, Biologics, Chemistry, Science related fields.

大学本科（硕士或以上优先），药学、生物、化学等相关自然学科专业Experienced QC operation and management;

丰富的QC运行和管理的经验；

Expertise in quality control principles and lab testing (especially biochemical analysis, practices and standards for the biopharmaceutical industry;

具有生物制药行业质量控制和各种实验检测（特别是生化检测分析），良好规范和相关标准的专业知识；

Capable to handle lab testing issue and lab investigation;

具有解决具体实验问题的能力，执行实验室调查；

Familiar to lab instruments management, calibration and validation;

熟悉实验室仪器管理，包括校验验证；

Familiar with the ChP/USP/EP, cGMP/EU GMP and ICH Q guidance;

熟悉中国药典、美国药典、欧洲药典、cGMP/欧盟GMP及ICHQ的相关要求；

Good communication and coordination ability;

具有良好的沟通协调能力；

5 years and more working experience in pharmaceutical analysis, large molecule experience preferred;

医药行业5年以上药物分析工作经验, 有大分子经验者优先；

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。

Familiar with Microsoft Office software.

熟悉微软办公软件

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 First, 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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If you voluntarily provide your resume or other personal information to us, it is deemed as you have thoroughly acknowledged and accepted BeiGene Job Applicant Privacy Policy. If you have any concern, please DO NOT submit your resume or any other personal information.