Principal Associate-Quality Assurance

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.
QMS Management质量管理体系管理
Be responsible for the establishment, maintenance and continuous improvement of the MIC Quality Management System, ensuring it supports compliant, inspection-ready and risk-controlled warehousing and distribution operations in accordance with China GSP requirements and Lilly quality standards.
负责MIC质量管理体系的建立、维护和持续改进，确保其支持符合中国GSP法规要求及礼来质量标准的仓储与分销运营，并保持检查准备状态和风险受控。
Manage the MIC GSP documentation system, including document creation, review, approval, issuance, revision, archival and lifecycle control, ensuring compliance with applicable regulatory and company requirements.负责MIC GSP文件体系的管理，包括文件起草、审核、批准、发布、修订、归档及全生命周期管理，确保符合相关法规及公司要求。
Manage deviation-related quality processes, including escalation, investigation, risk assessment, documentation, action tracking and closure of quality events in accordance with established procedures.管理偏差相关质量流程，包括质量事件的升级、调查、风险评估、文件记录、措施跟踪和关闭，确保符合既定程序要求。
Manage change control activities, including quality and regulatory impact assessment, implementation follow-up, effectiveness verification, documentation and stakeholder communication.管理变更控制活动，包括质量和法规影响评估、实施跟进、效果确认、文件记录和相关方沟通。
Manage CAPA processes, including risk-based action planning, implementation follow-up, effectiveness checks and closure tracking to support recurrence prevention and quality system improvement.管理CAPA流程，包括基于风险制定措施、实施跟进、效果检查和关闭跟踪，以支持问题预防和质量体系改进。
Plan and coordinate MIC internal self-inspections, assess quality system effectiveness, identify risks or compliance gaps, and follow up on remediation and improvement actions.计划并协调MIC内部自查，评估质量体系有效性，识别风险或合规差距，并跟进整改和改进行动。
Coordinate inspection and audit readiness activities for MIC, including Lilly GQA audits and regulatory inspections, by aligning with relevant functions, preparing required evidence, supporting inspection execution, and following up on post-inspection actions.协调MIC检查与审计准备活动，包括礼来GQA内部质量审计及官方检查，与相关职能部门对齐要求、准备所需证据材料、支持检查执行，并跟进检查后的相关行动。
Regulatory Compliance & Qualification Management 法规合规及资质管理
Manage the regulatory qualification lifecycle for MIC’s Drug Distribution License, including routine maintenance, renewal preparation and follow-up on compliance requirements.管理MIC药品经营许可证的法规资质生命周期，包括日常维护、换证准备以及合规要求的跟进。
Monitor, analyse and interpret China GSP requirements and relevant regulatory expectations, assess their impact on MIC business operations and the quality management system, and translate regulatory requirements into actionable processes, compliance strategies and improvement actions. Act as a bridge between regulators and internal teams by providing regulatory interpretation and quality compliance support, coordinating gap assessments, risk identification and remediation activities, and driving cross-functional alignment to ensure sustained regulatory compliance and inspection readiness for MIC.持续跟踪、分析并解读中国GSP法规及相关监管要求的变化，评估其对MIC业务运营和质量体系的影响，并将法规要求转化为可执行的流程、合规策略和改进措施。作为监管要求与内部团队之间的沟通桥梁，为相关职能团队提供法规解读和质量合规支持，协调差距评估、风险识别及整改活动，推动跨职能对齐，确保MIC持续符合监管要求，并保持检查准备状态。
Warehouse Quality Operations Management 仓储质量运营管理
Provide quality oversight for warehouse operations, including incoming product verification, returned goods management, equipment maintenance and calibration, pest control, environmental monitoring, and temperature and humidity control, to ensure applicable requirements are followed and risks are appropriately managed.对仓储运营进行质量监督，包括产品验收、退货管理、设备维护与校准、虫害控制、环境监测及温湿度控制，确保相关要求得到遵循且风险得到适当管理。
Quality Performance & Training Management 质量绩效与培训管理
Manage MIC quality performance monitoring, including monthly quality reporting, identification and escalation of key quality risks or trends, and communication of relevant quality information to support management review.管理MIC质量绩效监测，包括月度质量报告、关键质量风险或趋势的识别和升级，以及向管理层沟通相关质量信息以支持管理评审。
Manage GSP-related personnel training, qualification, job description management and employee health record oversight, ensuring personnel requirements are maintained and quality-related responsibilities are clearly defined.管理GSP相关人员培训、资质确认、岗位职责管理及员工健康档案监督，确保人员要求得到维护，质量相关职责清晰定义。
Backup Responsibilities & Business Continuity Support 后备职责及业务连续性支持
Act as backup for MIC document control responsibilities when required, ensuring continuity, compliance and effectiveness of the GSP documentation system.必要时担任MIC文件控制职责的后备人员，确保GSP文件体系的连续性、合规性和有效性。
Provide business continuity support for MIC incoming product quality release activities, ensuring release decisions remain compliant, timely and appropriately documented when backup support is required.为MIC成品入库质量放行活动提供业务连续性支持，确保在需要后备支持时放行决策合规、及时并得到适当记录。
Act as backup for MIC GSP Quality Responsible Person when required, including recall coordination, quality communication to management, and other critical quality processes.必要时担任MIC GSP质量负责人相关职责的后备人员，包括召回协调、向管理层进行质量沟通以及其他关键质量流程。
Perform other quality-related responsibilities as assigned, applying quality knowledge and coordinating with relevant functions to support MIC’s compliance and operational objectives.根据安排承担其他质量相关职责，运用质量专业知识并与相关职能部门协调，以支持MIC合规及运营目标。
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