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 a