Quality Expert Method Digitalization

The InsuLINK program is a strategic high-budget investment project that aims to establish two new insulin manufacturing sites in Germany (Frankfurt) and China (Beijing). The Quality Control group focuses on all QC topics involved in establishing, qualifying and operating these sites. Main topics include: Ensure timely set-up of Quality Control laboratories / Ensure harmonized processes in the laboratories / Develop concepts for equipment installation and qualification and elaborate respective documentation / Prepare analytical method transfers and follow-up during execution.

InsuLINK项目是一项战略性高预算投资项目，旨在在德国（法兰克福）和中国（北京）建立两个新的胰岛素生产基地。质量控制团队专注于建立、确认和运营这两个工厂所涉及的所有质量控制事项。主要工作包括：确保质量控制实验室的及时建立 / 确保实验室流程的统一协调 / 制定设备安装和确认的方案并编制相应文件 / 准备分析方法转移并跟进执行情况。

The QC Expert Method Digitalization will contribute to the establishment of the digital IFB QC/MQC environment, in particular the Lab Execution System (LES). This will be done in close collaboration with internal experts as well as external partners. He/she is responsible for coordinating an interdisciplinary, cross-functional project team to achieve project goals and milestones. He/she will also contribute as a Key User in this role and support the IFB QC/MQC laboratories in the evaluation, implementation, and optimization of the LES.

质量控制方法数字化专家将为建立数字化IFB质量控制/微生物质量控制（QC/MQC）实验室环境做出贡献，特别是实验室执行系统（LES）。这将与内部专家（以及外部合作伙伴密切合作完成。他/她负责协调跨学科、跨职能的项目团队，以实现项目目标和里程碑。他/她还将在此角色中作为关键用户做出贡献，并支持IFB质量控制/微生物质量控制实验室进行LES的评估、实施和优化。

Key tasks, responsibilities and accountabilities are listed as follows:

主要任务、职责和责任如下：

1. Project Coordination and Preparation: Preparation and coordination of the LES project from Phase 0 to Gate 3 Release in close collaboration with QC/MQC laboratories, internal subject matter experts, and external service providers. Planning, creation, and tracking of the project plan as well as definition of milestones for Gate 3 planning in alignment with all stakeholders.

项目协调和准备：与质量控制/微生物质量控制实验室、内部主题专家和外部服务提供商密切合作，准备和协调从第0阶段到Gate 3发布的LES项目。规划、创建和跟踪项目计划，以及与所有利益相关者协调定义Gate 3规划的里程碑。

2. Project Alignment: Alignment and linkage of IFB with the other sites for QC and MQC topics; participation in relevant cross-project alignment meetings.

项目协调：将IFB与其他工厂在质量控制和微生物质量控制主题上进行协调和关联；参加相关的跨项目协调会议。

3. Method Digitalization and Harmonization: Digitalization, harmonization, and qualification of test methods in the LES context with a focus on product testing, standards, reagents, and instrument management.

方法数字化和协调：在LES环境中对测试方法进行数字化、协调和确认，重点关注产品测试、标准、试剂和仪器管理。

4. Candidate Matrix & Method Collection: Collection and documentation of test methods in a candidate matrix including criteria such as sample throughput, complexity, and duration; clustering/grouping of methods for gap assessment.

候选矩阵和方法收集：在候选矩阵中收集和记录测试方法，包括样品通量、复杂性和持续时间等标准；对方法进行聚类/分组以进行差距评估。

5. Gap Assessment: Conducting gap assessments of the clustered methods together with the laboratory; benchmarking against global LES templates; identification of gaps and deviations.

差距评估：与实验室一起对聚类方法进行差距评估；与全球LES模板进行基准比较；识别差距和偏差。

6. IFB Transfer Management: Creation of an overview of methods that need to be transferred to IFB; review of existing transfer plans; clarification of timelines, dependencies, and IFB requirements. Acting as interface to external consultants, internal customers within the Sanofi network such as ITS, CSV, and the QC/MQC laboratories.

IFB转移管理：创建需要转移到IFB的方法概览；审查现有转移计划；明确时间表、依赖关系和IFB要求。作为与外部顾问、赛诺菲网络内部客户（如ITS、CSV）以及质量控制/微生物质量控制实验室的接口。

7. Technical Guidance and Coordination: Coordination of Key Users, external companies, and internal departments to achieve project milestones as the central point of contact for the LES project.

技术指导和协调：协调关键用户、外部公司和内部部门以实现项目里程碑，作为LES项目的中心联系点。

8. LES Implementation and Training: Supporting units in the implementation of the LES as well as introduction and training on the LES and digital processes within the units.

LES实施和培训：支持各单位实施LES，以及在各单位内介绍和培训LES和数字化流程。

9. System and Database Management: Processing, maintenance, and optimization of systems/databases (SAP, LIMS, OneLIMS); responsibility for master data management, data analysis, and interfaces to SAP.

系统和数据库管理：处理、维护和优化系统/数据库（SAP、LIMS、OneLIMS）；负责主数据管理、数据分析和SAP接口。

10. GMP Documentation: GMP-compliant documentation, creation of Standard Operating Procedures (SOPs), and regulatory-relevant pharmaceutical-technical documentation (e.g., validation/qualification documents).

GMP文档：符合GMP的文档编制、标准操作程序（SOP）的创建，以及与监管相关的药物技术文档（例如验证/确认文件）。

11. Reporting and KPIs: Supporting the creation of reports and KPIs in a clear and understandable manner to ensure transparency of project progress.

报告和关键绩效指标：以清晰易懂的方式支持创建报告和关键绩效指标，以确保项目进展的透明度。

12. Regulatory Compliance: Processing of events, change controls (CCs) & CAPAs; responding to regulatory inquiries and participating in regulatory authority inspections.

法规合规：处理事件、变更控制（CC）和纠正预防措施（CAPA）；回应监管查询并参与监管机构检查。

About you 任职资格:

Experience:

• Experience in quality control, laboratory processes, and GxP requirements and regulations.

• Experience in method digitalization and harmonization in pharmaceutical QC laboratories, preferably experience with Labware.

• The candidate should be able to independently handle the essential workflows in the QC laboratory within the quality assurance systems framework, based on practical experience.
• 在质量控制、实验室流程以及GxP要求和法规方面的经验。

• 在制药质量控制实验室的方法数字化和协调方面的经验，最好有Labware经验。

• 候选人应能够基于实际经验，在质量保证系统框架内独立处理质量控制实验室的基本工作流程。

Soft skill:

• Recognized team player

• Good and transparent communication skills; customer/support/team orientation

• Willingness to perform and assertiveness

• Understanding of "servant leadership"

• Adaptable and flexible in responding to new ideas and changes

• Consistent and quality-oriented

• Courage to challenge the status quo and propose changes

• Open feedback culture as the foundation of collaborative work
• 公认的团队合作者

• 良好且透明的沟通技巧；客户/支持/团队导向

• 工作意愿和果断性

• 理解"服务型领导"

• 适应性强，灵活应对新想法和变化

• 始终如一且注重质量

• 勇于挑战现状并提出变革

• 开放的反馈文化作为协作工作的基础

Technical skill:

• Knowledge of Lab Execution Systems (LES), preferably Labware, and their integration into existing laboratory infrastructures; affinity for electronic systems and applications

• Very good IT skills – particularly SAP, Word, and Excel

• LEAN experience, including process optimization, is desirable

• Good knowledge of fundamental cGMP regulations

• Independent, self-responsible work in accordance with GMP requirements

• Willingness to pursue further training

• Experience in roll-outs of LIMS and Lab Execution Systems as well as project preparation phases (Phase 0 to Gate 3 Release) is desirable

• 了解实验室执行系统（LES），最好是Labware，以及它们与现有实验室基础设施的集成；能够快速适应和掌握电子系统和应用程序

• 非常好的IT技能 - 特别是SAP、Word和Excel

• 具有精益经验，包括流程优化，优先

• 对基本cGMP法规有良好的了解

• 按照GMP要求独立、自主地工作

• 愿意接受进一步培训

• 具有LIMS和实验室执行系统推广以及项目准备阶段（第0阶段到Gate 3发布）的经验者优先

Education: The candidate holds a completed Bachelor degree or above in natural sciences or engineering 

• 教育背景: 候选人持有理学或工学学士学位或以上学历

• Languages: English (business fluent / negotiation level)

• 语言要求: 英语（商务流利/谈判水平）)

• Take the Lead: Aim Higher, Act for Patients, Be Bold, Lead Together
• 敢为人先: 志存高远，心系患者，敢于创新，聚力同行

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