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

Closing Date

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 of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.