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