Sr. 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.

Purpose:

This Quality Compliance role is accountable for maintaining an effective, inspection-ready quality management system that complies with China drug GSP requirements, applicable regulatory expectations and Lilly global quality standards. The role provides quality input, conducts risk assessments and coordinates across functions to support compliant operations, product quality, patient safety and business continuity throughout storage and distribution.

该岗位负责维护有效且具备检查准备状态的质量管理体系，确保其符合中国药品GSP要求、适用监管期望及礼来全球质量标准。该岗位通过提供质量意见、开展风险评估并协调跨职能合作，支持仓储与分销全过程的合规运营、产品质量、患者安全和业务连续性。

Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The requirements of any position may change over time and may include additional responsibilities not specifically described in this job description. Consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

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.

Oversee the MIC GSP document management system, including document drafting, review, approval, issuance, revision, archiving and lifecycle control, ensuring compliance with applicable regulatory and company requirements.

Manage deviation-related quality processes, including escalation, investigation, risk assessment, documentation, action tracking and closure of quality events in accordance with established procedures.

Manage change control activities, including quality and regulatory impact assessment, implementation follow-up, effectiveness verification, documentation and stakeholder communication.

Manage CAPA processes, including risk-based action planning, implementation follow-up, effectiveness checks and closure tracking to support recurrence prevention and quality system improvement.

Plan and coordinate MIC internal self-inspections, assess quality system effectiveness, identify risks or compliance gaps, and follow up on remediation and improvement actions.

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.

Regulatory Compliance & Qualification Management 法规合规及资质管理

Manage the lifecycle of MIC’s Drug Distribution License, including routine maintenance, renewal preparation and follow-up on applicable compliance requirements.

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.

Training Management培训管理

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.

Backup Responsibilities & Business Continuity Support 后备职责及业务连续性支持

Serve as backup for day-to-day MIC document control activities when required, helping ensure the continuity, compliance and effectiveness of the GSP documentation system.

Provide business continuity support for MIC finished-product receipt and quality release activities, ensuring that release decisions remain compliant, timely and appropriately documented when backup support is required.

Perform other quality-related responsibilities as assigned, applying quality knowledge and coordinating with relevant functions to support MIC’s compliance and operational objectives.

Minimum Qualification Requirements:

§ Bachelor’s degree or above, with a major in pharmacy, chemistry or a related scientific discipline.

本科或以上学历，药学，化学或相关专业。

§ At least three years of QA experience.

至少3 年以上的 QA 经验。

§ Proficient in English communication, with the ability to read, write and communicate effectively in business and technical contexts.

具备良好的英语沟通能力，能够在业务及技术场景中有效进行英文阅读、书面表达和口头沟通。

Other Information/Additional Preferences:

§ Licensed pharmacist qualification is preferred.

执业药师优先。

§ Good leadership, communication and influencing skills, with a self-motivated and proactive attitude and the ability to foster collaboration across functions.

具备良好的领导力、沟通能力和影响力，积极主动，并能够促进跨部门/职能协作。

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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