生物药研发QA经理
Description
General Description
This role will serve as an on-site QA for the Shanghai Biologics Technical Development (Bio TD) laboratory, providing day-to-day quality support and oversight. The individual will drive the effective implementation and continuous improvement of a phase-appropriate quality system at the Shanghai site and ensure that development activities comply with data integrity and applicable regulatory requirements.
The role will focus on providing quality oversight and support for Bio TD development activities, primarily covering key development areas such as cell line development, process development, analytical method development, formulation and drug product development, and technology transfer. The role will also support key activities and studies, including Research Cell Bank (RCB) establishment, toxicology batch material production and release, early-stage reference standard filling, product characterization, and late-stage studies related to critical quality attributes (CQAs), comparability, and process characterization, ensuring high-quality and traceable R&D documentation and data to support IND and BLA filings.
This role will report to the Biologics Development QA Team Lead and work closely with QA teams in Beijing, Guangzhou, and Suzhou to drive the harmonization and continuous improvement of quality systems, workflows, and quality standards across the four Bio TD sites, enhancing the consistency and compliance of quality management throughout biologics development.
该职位作为生物药技术开发实验室（Bio TD）的现场QA，负责为上海Bio TD实验室提供日常质量支持和监督，推动适用于生物药开发阶段的质量体系在上海基地有效实施并持续改进，确保研发活动符合数据可靠性及相关法规要求。
该职位将重点对Bio TD生物研发活动提供质量监督和支持，主要涵盖细胞系开发、工艺开发、分析方法开发、处方及制剂开发、技术转移等核心研发活动；同时支持研究细胞库（RCB）建立、毒理批材料生产和放行、早期标准品灌装、产品表征，以及临床后期关键质量属性（CQA）相关研究、可比性研究和工艺表征等关键活动和研究，确保形成高质量、可追溯的研发文件和数据，为IND及BLA申报提供支持。
该职位向生物药研发QA团队负责人汇报，并与北京、广州和苏州QA团队紧密合作，推动Bio TD四个基地质量体系、工作流程和质量标准的协调统一及持续改进，提升开发阶段质量管理的一致性和合规水平。
Job Description
1. Establish and maintain a phase-appropriate quality system for biologics development and provide quality oversight of Bio TD laboratory activities. Support the harmonization and continuous improvement of quality systems and standards across the four Bio TD sites (Beijing, Shanghai, Suzhou, and Guangzhou).
建立并维护适用于生物药开发阶段的质量体系，对Bio TD实验室活动提供质量监督；推动四个Bio TD基地（北京、上海、苏州、广州）质量体系和标准的协调统一及持续改进。
2. Establish, maintain, and continuously improve quality system-related workflows and processes.
建立、维护并持续优化质量体系相关工作流程。
3. Draft and review quality system-related documents.
参与质量体系相关文件的起草和审核。
4. Participate in self-inspections and follow up on CAPA implementation.
参与自检，并跟进纠正与预防措施（CAPA）的实施。
5. Review biologics development project documents, including study plans/reports, test methods, test records, process procedures, batch production records, and process development reports. Independently provide QA support and review technical documentation in at least one Bio TD area, such as Cell Line Development, Upstream Process Development, Downstream Process Development, Formulation and Drug Product Development, or Analytical Research Development.
参与生物药研发项目相关文件的审核，包括研究计划/报告、测试方法、测试记录、工艺规程、批生产记录和工艺开发报告等；能够独立承担至少一个Bio TD技术领域的QA支持和技术文件审核工作，例如细胞系开发、上游工艺开发、下游工艺开发、处方及制剂开发或分析研究开发。
6. Manage controlled documents, including document distribution and archiving. Ensure that Bio TD development documentation is effectively managed and controlled throughout its lifecycle and that complete, accurate, and traceable source documentation is maintained to support IND and BLA filings.
负责受控文件管理，包括文件分发和归档；确保Bio TD研发文件在整个生命周期内得到有效管理和控制，并形成完整、准确、可追溯的源文件，为IND和BLA申报提供支持。
7. Support personnel training, including new employee training, data integrity training, and SOP training.
支持人员培训，包括新员工培训、数据可靠性培训和SOP培训。
8. Provide quality oversight of equipment, samples, Research Cell Banks (RCBs), reference standards, and materials to ensure compliance with applicable quality and regulatory requirements.
对仪器设备、样品、研究细胞库（RCB）、标准品及物料管理提供质量监督，确保符合相关质量及法规要求。
9. Provide QA support for computerized system management to ensure compliance with data integrity requirements.
为计算机化系统管理提供QA支持，确保符合数据可靠性要求。
10. Provide QA support for vendor management and outsourced Bio TD activities to ensure that externally generated documentation and data meet applicable quality requirements and support IND and BLA filings.
为供应商管理及Bio TD相关外包活动提供QA支持，确保外部产生的文件和数据符合相关质量要求，并支持IND和BLA申报。
11. Perform other duties as assigned by the line manager.
完成直线经理安排的其他相关工作。
Qualification：
1. Bachelor’s degree or above in Pharmacy, Biology, Biochemistry, Chemistry, or a related field.
本科及以上学历，药学、生物学、生物化学、化学或相关专业。
2. At least 8 years of experience in the pharmaceutical industry, including at least 5 years of QA/QC experience. Experience in biologics laboratories, laboratory computerized system management, and project management is preferred.
8年以上制药行业工作经验，其中至少5年QA/QC相关工作经验；具有生物制剂实验室背景、实验室计算机化系统管理及项目管理经验者优先。
3. Familiar with data integrity, GLP, GMP, and other applicable regulatory and quality requirements.
熟悉数据可靠性、GLP、GMP及其他相关法规和质量要求。
4. Familiar with common biologics laboratory techniques. Technical background or relevant experience in at least one biologics development area, such as Cell Line Development, Upstream Process Development, Downstream Process Development, Formulation and Drug Product Development, or Analytical Development, is a plus.
熟悉常见的生物药实验室技术；具备细胞系开发、上游工艺开发、下游工艺开发、处方及制剂开发或分析开发等至少一个生物药开发技术领域的专业背景或相关经验者优先。
5. Strong execution and time management skills, with the ability to plan work effectively, manage priorities, and deliver results efficiently.
具备较强的执行力和时间管理能力，能够合理制定工作计划、有效管理工作优先级并高效完成工作。
6. Strong problem-solving skills, with the ability to independently identify, analyze, and resolve quality-related issues.
具备较强的问题解决能力，能够独立识别、分析并解决质量相关问题。
7. Strong communication and collaboration skills, with the ability to communicate proactively and work effectively with cross-functional teams.
具备良好的沟通和团队协作能力，能够积极主动沟通，并与跨职能团队有效合作。
8. Strong attention to detail and organizational skills, with good follow-up capabilities.
注重细节，具备良好的组织协调和工作跟进能力。
9. Demonstrated learning agility, flexibility, and accountability, with the ability to adapt to changing business needs.
具备良好的学习能力、适应能力和责任意识，能够适应不断变化的业务需求。
10. Good written and spoken English, with the ability to communicate effectively in English in a cross-functional working environment.
具备良好的英语书面和口头沟通能力，能够在跨职能工作环境中使用英语进行有效沟通。
11. Proficient in PowerPoint and Excel, with the ability to effectively organize, analyze, and present information.
熟练使用PowerPoint和Excel，具备良好的信息整理、分析及汇报展示能力。
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
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