QC Expert

Main Responsibilities主要职责：  Build strong quality control organization related Med-Chemistry GMP activities. 建立支持药物化学组GMP相关活动的坚实的质量控制团队。  Commitment to Quality and Compliance, operate at the highest global standards, hominization with global quality standard to achieve continual improvement. 遵从质量和合规要求，以全球最高标准运营，持续改进，践行全球质量标准化。  Responsible for technical assessment for a contract lab to support GMP operation, support quality activities in the contract lab and co-oversight. 负责支持GMP运营的合同实验室的技术评估，同时协同监督合同实验室相关的质量活动。  Ensure that analytical methods can be successfully transferred and validated in QC lab, and evaluate the scientific validity, feasibility, and compliance of the analytical methods based on the method parameters or data provided by ARD.  确保分析方法可以顺利在QC进行转移/验证工作，针对ARD提供的方法参数或数据信息评估其分析方法的科学性、可行性以及合规性。  Ensure that the parameters in the specification meet the regulatory requirements of the corresponding clinical supply market, while also meeting the laboratory’s testing capabilities. 确保质量标准中的参数满足对应临床供应市场的法规要求，同时满足实验室检测能力。  To ensure that all necessary testing is carried out and the associated records evaluated. 确保所有必要检测顺利开展，且评估相关记录。  To ensure stability test/study conducted as per plan (product specific protocol, overall schedule). 确保按计划进行稳定性检测/研究。（如特定产品的方案、总体进度）  To ensure the qualification and maintenance of the department, premises and equipment. 确保部门、场所和设备的确认和维护。  To ensure that the appropriate analytical method validations are performed as per plan. (validation protocol, validation report, overall schedule) 确保按照计划完成适当的分析方法验证工作。（如验证方案、验证报告、总体进度的把控）  To ensure that the required initial and continuing training of the department personnel is carried out and adapted according to need. 确保部门人员完成必要的入职和更新类培训，并根据需要进行调整。  Establish key performance indicator (KPI) for quality control department and provide trend of quality performance periodically. 建立质量控制部门关键业务指标（KPI），并定期回顾质量绩效的趋势。  Provide leadership, guidance and development opportunities for direct reports. 领导并辅导直接汇报的下属，提供发展机会。  Coach and promote process standardization. Facilitate annual performance goal setting, performance review, talent review and IDP with employees as for people development. 在个人发展方面，辅导并推进流程标准化，并指导员工开展年度绩效目标设定、绩效评定、人才复盘和个人发展计划的设定。  Other duties as assigned by superior. 完成上级交办的其他工作。 Job Requirements任职资格:  Minimum of 5 years of experience in GMP analytical Lab in pharmaceutical industry, and at least more than 7 years analytical method validation background, and at least more than 3 years early phase project analytical experience. 至少5年的制药行业GMP分析实验室工作经验，并至少7年以上的分析方法验证相关技术背景，至少3年以上早期临床项目分析经验。  Capability of controlling and completing multiple issues with a clear sense of priority. 具备把控和处理多事项的能力，具有清晰的事物优先意识。  Demonstrated and experience in leading and driving high performing teams. 具有领导和带领高绩效团队的经验。  Ability to analyze and resolve issues. 具备分析和解决问题的能力。  English: fluent in writing and speaking. 英语水平：口语和书面表达流利。 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 BeOne 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 求职者隐私申明： 百济神州致力于尊重和保护您的个人信息权利，并承诺依据合法、正当、必要和诚信的原则处理您的个人信息（包括个人敏感信息 ）。 由于百济神州在全球范围内开展业务，我们可能需要基于人力资源管理等合理业务目的而将您的个人信息发送和/或存储在位于您所在国家以外其他国家（例如：美国）的服务器和数据库中，详情参见百济神州《求职者隐私政策》（百济神州官网 - 隐私政策 - 求职者隐私政策）。 如您主动向我们提供您的简历信息或其他个人信息，则视为您已经充分理解并确认接受百济神州《求职者隐私政策》内容。如您对此有任何疑问的，请勿提交简历信息或其他个人信息。 BeOne is committed to respect and protect your personal information rights, and will process your personal information, including your sensitive personal information, based on the principles of legality, legitimacy, necessity, and integrity. Due to the reasonable business need for human resource management as a result of BeOne’s global operation, your personal information may be transferred and/ or stored in a server/database located in a third country (e.g., the United States) other than your own country. For further details, please refer to BeOne Job Applicant Privacy Policy (BeOne official website - Privacy Policy - Job Applicant Privacy Policy). If you voluntarily provide your resume or other personal information to us, it is deemed as you have thoroughly acknowledged and accepted BeOne Job Applicant Privacy Policy. If you have any concern, please DO NOT submit your resume or any other personal information.