QC Associate Director

Typical Accountabilities 主要职责 Technical & GMP Leadership 技术与GMP领导 • Maintain and continuously improve GMP and GLP compliance in Analytical Laboratory operations. 维护并持续改进化学实验室日常运作中的GMP和GLP符合性。 • Provide analytical subject matter expertise for complex troubleshooting, deviations, OOS/OOT investigations, CAPA and technical risk assessments. 为复杂问题解决、偏差、OOS/OOT调查、CAPA及技术风险评估提供分析专业支持。 • Support regulatory inspections, self-inspections and audits, including preparation of technical responses and remediation actions. 支持法规检查、自检和审计，包括技术答复及整改行动的准备。 • Assess analytical regulatory changes and pharmacopeial updates and translate them into practical site implementation plans. 评估分析相关法规和药典更新，并转化为可执行的工厂落地计划。 New Product Introduction & Transfer 新产品引入与转移 • Lead QC workstreams for new product introduction, site transfer and repurposing projects, ensuring clear scope, resource, equipment, method, stability and timeline assumptions. 主导新产品引入、场地转移及产品调整项目中的QC工作流，确保范围、资源、设备、方法、稳定性及时间计划等假设清晰。 • Own or coordinate analytical method transfer, verification/validation, equipment qualification and laboratory readiness activities for drug product, API, excipients, cleaning validation and stability testing. 负责或协调成品、原料药、辅料、清洁验证及稳定性检验相关的方法转移、确认/验证、设备确认和实验室准备工作。 • Perform early technical and capacity assessments, identify critical dependencies and risks, and establish integrated plans with sending units and cross-functional project teams. 开展前期技术及产能评估，识别关键依赖与风险，并与转出方及跨职能项目团队建立整合计划。 • Provide analytical input to CMC dossiers, change controls, specifications, comparability strategies, launch readiness and post-transfer lifecycle management. 为CMC注册资料、变更控制、质量标准、可比性策略、上市准备及转移后生命周期管理提供分析支持。 Laboratory AI, Digital & Automation Deployment 实验室AI、数字化与自动化部署 • Identify and prioritize high-value AI, digital and automation use cases aligned with laboratory capacity, quality, safety and productivity needs. 结合实验室产能、质量、安全和效率需求，识别并优先排序高价值AI、数字化和自动化应用场景。 • Lead or support deployment of automated sample preparation/testing, robotic workstations, laboratory orchestration, AMR-enabled material flow, LIMS/LabX integration and AI-assisted data analytics. 主导或支持自动化样品制备/测试、机器人工作站、实验室编排、AMR物料流、LIMS/LabX集成及AI辅助数据分析的部署。 • Translate business needs into user requirements, process maps, data and integration requirements, validation strategy, acceptance criteria and benefit tracking. 将业务需求转化为用户需求、流程图、数据及系统集成要求、验证策略、验收标准及效益跟踪。 • Partner with QA, IT, Engineering, vendors and global technical teams to ensure solutions meet GxP, data integrity, cybersecurity, CSV/CSA and lifecycle management requirements. 与QA、IT、工程、供应商及全球技术团队协作，确保解决方案符合GxP、数据完整性、网络安全、CSV/CSA及生命周期管理要求。 • Drive adoption, standard work, knowledge transfer and sustainable use of deployed solutions; monitor performance and continuously optimize workflows. 推动已部署方案的采用、标准作业、知识转移和可持续使用，并监控绩效、持续优化工作流。 Equipment, Systems & Project Delivery 设备、系统与项目交付 • Provide technical oversight for analytical instruments and laboratory systems, including selection, qualification, maintenance strategy and lifecycle planning. 对分析仪器和实验室系统提供技术监督，包括选型、确认、维护策略及生命周期规划。 • Lead major technical changes and projects with clear governance, decision gates, deliverables, owners, dependencies, risks and milestones. 通过清晰的治理、决策门、交付物、责任人、依赖、风险和里程碑，主导重大技术变更和项目。 • Develop resource and investment estimates for technical projects and support CAPEX/OPEX business cases and benefit realization. 制定技术项目资源与投资估算，支持CAPEX/OPEX商业案例及效益实现。 • Complete other projects or tasks based on business needs. 完成其他业务驱动的项目和任务。 S.H.E. Responsibilities SHE职责 • Promote a safety-first culture and ensure compliance with SHE policies, standards and local legislation. 推动安全至上的文化，确保符合SHE政策、标准及当地法规。 • Proactively identify SHE risks in laboratory processes and technology deployment and implement appropriate controls. 主动识别实验室流程及技术部署中的SHE风险，并实施适当控制。 • Apply safer methods and technologies to reduce manual handling, ergonomic exposure, chemical exposure and waste. 应用更安全的方法和技术，减少人工操作、人体工学暴露、化学品暴露和废弃物。 Education, Experience and Training 教育、工作经验和培训 • Bachelor’s degree or above in Pharmacy, Chemistry, Analytical Chemistry, Biology, Engineering or a related scientific/technical discipline. 药学、化学、分析化学、生物、工程或相关科学/技术专业本科及以上学历。 • Substantial experience in a pharmaceutical QC laboratory and strong knowledge of GMP, GLP, data integrity and major global pharmacopoeias. 具备丰富的制药QC实验室经验，熟悉GMP、GLP、数据完整性及全球主要药典。 • Demonstrated experience in analytical method transfer and validation/verification, preferably including successful new product introduction or site transfer. 具备分析方法转移和验证/确认经验，优先考虑具有成功新产品引入或场地转移经验者。 • Practical experience delivering laboratory digitalization, AI or automation projects in a regulated environment is preferred. 优先考虑具备在受监管环境中交付实验室数字化、AI或自动化项目的实践经验者。 • Experience with laboratory systems and automation platforms such as LIMS, CDS, LabX, robotics, automated sample preparation or data analytics is desirable. 具备LIMS、CDS、LabX、机器人、自动化样品制备或数据分析等实验室系统及自动化平台经验者优先。 Capabilities 能力 • Strong analytical science expertise with structured problem-solving, root-cause analysis and risk-management capability. 具备扎实的分析科学专业能力，以及结构化问题解决、根因分析和风险管理能力。 • Ability to define user requirements, evaluate technical solutions and manage validation, integration and lifecycle risks. 能够定义用户需求、评估技术方案，并管理验证、集成及生命周期风险。 • Ability to convert technology opportunities into credible business cases with measurable quality, capacity, productivity and cost benefits. 能够将技术机会转化为可信的商业案例，并量化质量、产能、效率及成本收益。 • Strong project leadership, stakeholder management, communication and influencing skills in a matrix organization. 具备较强的项目领导、利益相关方管理、沟通及矩阵式影响力。 • Functional mastery of written and spoken English; strong digital literacy and learning agility. 熟练掌握书面和口语英语；具备良好的数字化素养和学习敏捷性。 Date Posted 03-Nov-2026 Closing Date 30-Mar-2027 AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range