Senior 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:

The Quality Unit Leader is responsible for providing quality oversight of MIC’s GSP-governed warehousing and distribution operations to ensure compliance with China GSP requirements, applicable regulatory expectations, and Lilly Global Quality Standards (GQS). The role ensures timely product release and provides quality oversight of warehouse facilities, utilities, and equipment so that products are stored under safe, secure, and appropriate temperature-controlled conditions. The role also conducts deviation investigations and root-cause analyses and ensures that documents and records are accurate, complete, and maintained in full compliance with GSP and Lilly GQS requirements.

该岗位负责对MIC受GSP监管的仓储与分销运营实施质量监督，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。及时完成产品放行，并对仓库设施、公用系统及设备进行质量监督，确保产品在安全、可靠且符合要求的温控条件下贮存。开展偏差调查和根本原因分析，维护文件和记录的准确性与完整性，确保充分符合GSP及礼来GQS要求。

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

• Provide quality oversight of warehouse operations, including product receipt and acceptance, returned goods management, equipment maintenance and calibration, pest control, environmental monitoring, and temperature and humidity control, to ensure that applicable requirements are followed and risks are appropriately managed.

• Investigate and manage deviations and quality events related to MIC products, ensure that event handling complies with Lilly GQS requirements, and follow up effectively on the implementation of corrective and preventive actions.

• Manage the translation of original manufacturers’ Certificates of Analysis (CoAs), ensuring that accurate translations are provided to warehouse acceptance personnel in a timely manner. Manage and continuously improve the product release process, review documentation and records for incoming products, and complete product release activities promptly in electronic systems and paper records, ensuring compliance with GSP requirements and Lilly standards.

• Review and make quality decisions on returned and rejected products and provide oversight of the handling process for returned and rejected products.

• 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.

• Draft and revise SOPs related to the assigned areas of responsibility.

• Prepare and execute warehouse temperature mapping studies and periodic validation of temperature and humidity monitoring systems to ensure that warehouse conditions meet product storage requirements.

• Provide quality oversight of calibration, validation and qualification activities for MIC warehouse facilities, utilities and equipment, and develop annual maintenance plans and validation master plans for relevant systems.

• Ensure the secure management of specially controlled products and other applicable products.

• Serve as Business QA for computerized systems by coordinating and participating in related activities, including user requirements definition, validation, supplier management, and change control.

• Act as backup to the MIC GSP Quality Responsible Person when required, including for recall coordination, quality communications to management, and other critical quality processes.

• As a backup, perform quality management activities for MIC’s contracted warehouses in other provinces, including product batch release at regional distribution centers.

• As a backup, serve as the coordinator for third-party quality management and oversee the end-to-end management of GMP service providers, including risk assessments, change control, establishment and maintenance of qualified supplier lists, coordination of corporate supplier audits, periodic quality assessments, quality agreements, records and document maintenance, and TPO system activities.

• Perform other tasks assigned by the supervisor.

Minimum Qualification Requirements:

• Bachelor’s degree or above in pharmacy, chemistry or a related scientific discipline.

本科或以上学历，药学、化学或相关科学专业。

• At least three years of QA experience in pharmaceutical distribution or wholesale operations, with a solid understanding of GSP requirements.

至少具有三年药品经营或批发领域QA经验，并熟悉GSP要求。

• 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.

• 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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