About this role
At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.
Manage qualification, risk-based quality evaluation and on-site assessment of suppliers, distributors, carriers and GMP service providers supporting MIC operations in accordance with Lilly third-party/external party management requirements, including initial qualification, third-party risk assessment and classification, periodic re-evaluation, audit planning, audit execution, follow-up of audit observations and closure of agreed actions. 根据礼来第三方/外部合作方管理要求，负责对支持MIC运营的供货单位、经销商、承运商及GMP服务商进行准入、基于风险的质量评估和现场评估，包括初始准入、第三方风险评估与分类、定期再评估、审计计划制定、审计实施、审计发现项跟进及整改措施关闭。
Maintain qualification and license information for suppliers, distributors, carriers and GMP service providers in applicable systems; ensure licenses, permits, product-related qualifications and other required information remain complete, accurate, valid and up to date.负责在系统中维护供货单位、经销商、承运商及GMP服务商的资质和证照信息，确保相关证照、许可、产品资质及其他必要信息完整、准确、有效并保持最新状态。
Manage quality agreements and, where required, third-party management plans with suppliers, distributors, carriers and GMP service providers in accordance with Lilly requirements, including drafting or review, alignment of quality responsibilities, governance and monitoring expectations, change notification requirements, periodic review, and retention of executed agreements.根据礼来要求，负责供货单位、经销商、承运商及GMP服务商质量协议及必要时第三方管理计划的管理，包括起草或审核、质量职责对齐、治理与监督要求、变更通知要求、定期回顾及已签署协议的归档保存。
Provide quality training, communication and compliance oversight for distributors, carriers and GMP service providers as appropriate; support interpretation and implementation of applicable GSP regulations, Lilly global quality standards, Lilly third-party/external party management requirements and MIC procedures.
在适当情况下负责对经销商、承运商及GMP服务商开展质量培训、沟通及合规性监督，支持适用GSP法规、礼来全球质量标准、礼来第三方/外部合作方管理要求及MIC流程的理解和落实。
Oversee routine performance of distributors, carriers and GMP service providers in accordance with Lilly third-party oversight and performance monitoring expectations, including review of quality indicators, transportation controls, temperature management, delivery performance, documentation completeness, supplier commitments, recurring assessment needs, and timely escalation of recurring or significant issues to drive continuous improvement.
根据礼来第三方监督和绩效监测要求，负责对经销商、承运商及GMP服务商进行日常绩效监督，包括质量指标、运输过程控制、温度管理、交付表现、文件记录完整性、供应商承诺事项、定期评估需求等方面的回顾，并对重复发生或重大问题进行及时升级，推动持续改进。
Lead or support handling of transportation excursions, distributor quality issues and quality events related to distributors, carriers and GMP service providers in accordance with Lilly quality event escalation and third-party management expectations, including deviation assessment, complaint investigation, CAPA follow-up, effectiveness verification and escalation or discontinuation recommendation where quality or compliance performance is unacceptable.
根据礼来质量事件升级和第三方管理要求，负责运输异常、经销商质量问题以及与经销商、承运商和GMP服务商相关质量事件的处理，包括偏差评估、投诉调查、CAPA跟进、有效性确认，以及在质量或合规表现不可接受时提出升级或停止使用建议。
Monitor third-party changes that may impact MIC product quality, data integrity, regulatory compliance or service continuity, including changes to service scope, facility/location, key personnel, computerized systems, subcontractors or quality systems, and ensure appropriate assessment, approval, documentation and follow-up actions are completed.
跟进可能影响MIC产品质量、数据完整性、法规符合性或服务连续性的第三方变更，包括服务范围、设施/地点、关键人员、计算机化系统、分包商或质量体系变更，并确保完成适当的评估、批准、文件记录及后续行动。
Support execution of returns and recalls in collaboration with relevant functions and external partners, ensuring activities are performed in accordance with approved procedures, regulatory requirements, Lilly third-party management expectations and assigned quality responsibilities.
与相关职能和外部合作方协作，支持退货和召回的执行，确保相关活动符合已批准程序、法规要求、礼来第三方管理期望及分配的质量职责。
Review inbound product documentation and records and perform product release activities in a timely and compliant manner; manage and continuously improve the product release process; translate CoA and ensure timely delivery of translated reports to warehouse verification personnel.
负责审核入库产品相关文件及记录，并及时、合规地完成产品放行；负责产品放行流程的管理和持续优化；负责原厂检验报告的翻译，并将译文及时传递给仓库验收人员。
Establish and maintain product quality dossiers, customer quality records, service provider quality files and applicable quality standards, ensuring relevant information remains complete, accurate and up to date.
负责建立和维护药品质量档案、客户质量档案、服务商质量档案及适用质量标准，确保相关信息完整、准确并保持最新状态。
Serve as QA coordinator for drug traceability management, periodically review serialization code scanning rates and related indicators, and follow up on traceability issues to ensure compliance with regulatory traceability requirements.
作为药品追溯管理的质量协调人，定期检查追溯码扫描率等相关指标，并跟进追溯相关问题，确保符合法规可追溯性要求。
Support future Regional Distribution Centre quality management activities as business scope evolves, including readiness assessment, quality process implementation, external partner oversight and ongoing compliance monitoring.
随着业务范围的发展，支持未来区域分销中心的质量管理活动，包括准备状态评估、质量流程实施、外部合作方监督及持续合规性监控。
Draft and revise SOPs related to assigned responsibilities.
负责起草和修订职责范围内相关SOP。
Perform other tasks assigned by the supervisor.
完成主管安排的其他工作。
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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