At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

岗位描述：

Position Description:

该岗位作为中国外部制造的成员，需作为主要的质量联系人负责外部合作伙伴的生产相关活动质量监督和支持。支持职能包括批处置和产品测试、验证、变更管理、偏差管理、周期性审核、审计、投诉管理和文件管理。

The position will initially be a member of China External Manufacturing and will function as the primary Quality Contact for providing quality oversight and support for manufacturing activities associated with external partnerships. The support activities related to batch disposition and product testing, validation, Change Management, Deviation Management, Periodic reviews, Auditing, Complaints Management and Document Control.

主要职能：

Key Objectives/Deliverables:

建立管理外部生产合作伙伴的质量体系。

Create quality systems to manage external manufacturing partners.

确保外部生产合作伙伴及团队自身运作符合GMP和适合的礼来GQS。

Ensure GMP and appropriate Lilly GQS compliance for external manufacturing partners and the team’s own operations.

对外部生产合作伙伴实施适当的礼来质量管理，确保产品成功上市。

Implement appropriate Lilly Quality Governance to external manufacturing partners to assure successful products launching with required quality.

参与业务规划，确保有足够的资源来支持合规和业务需求。

Participate in business planning to ensure adequate resources are available to support compliance and business needs.

根据需求，参与产品批释放、验证和偏差相关的问题解决和日常决策。

Engage in problem-solving and day-to-day decision-making associated with product batch release, validation, and deviations, as needed.

结合适用的质量源于设计的理念，持续地努力减少偏差、投诉和待执行的质量活动。

Incorporate Quality by Design concepts where appropriate and strive to continuously reduce deviation, complaints and open quality actions.

与外部生产合作伙伴的质量领导建立良好的合作关系，共同制定决策权的详细认知。

Create a strong collaborative working relationship with the external manufacturing partners’ Quality leaders. Jointly develop a detailed understanding of decision-making rights.

与CEM领导合作，建立高凝聚力团队，管理外部生产合作伙伴。

Partner with CEM leader to create a strong cohesive team to manage the external manufacturing partners.

与礼来全球制造和质量人员合作，学习其他地方的最佳做法。

Work with global Lilly manufacturing and quality staff to learn best practices that exist elsewhere.

*遵守HSE各项管理流程，履行安全生产职责要求。

Follow various HSE management procedures and fulfill the work safety responsibilities.

基本要求：

Basic Requirements:

具有五年以上从事药品生产、技术服务和/或质量管理的GMP相关经验。

5+ years GMP experience including roles associated with production support, TS/MS and/or Quality.

本科学历（化学、生物、生命科学、制药或工程相关专业优先）。

Bachelor or equivalent (Chemistry, Biology, Life Sciences, Pharmacy or Engineering related degree preferred).

英语流利。

English fluency.

其他要求：

Additional Preferences:

较强的口头及书面交流沟通技巧。

Demonstrate strong oral and written communication and interpersonal interaction skills.

在优先、执行和建立关系网有较强的能力。

Significant leadership success in prioritization, implementation, relationship building and networking.

有制定或执行质量体系的经验。

Background in development or implementation of quality systems.

其他信息：包括履行该岗位所需的工作时间安排（轮班或加班），出差或环境要求。

Other Information: Include any work schedule (shift, overtime), travel or environment requirements necessary for the performance of the position.

需要按需出差

Need to be available to travel.

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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