SMQC 运营团队leader

Job Description:

1、负责SMQC运营团队的日常管理，统筹运营计划执行、资源协调、进度跟踪及交付达成，确保运营活动安全、合规、高效开展。

Responsible for the daily management of the SMQC operations team, including coordinating operation plan execution, resource coordination, progress tracking and delivery achievement, ensuring that operational activities are carried out safely, compliantly and efficiently.

2、建立、优化并落实运营相关流程、SOP及管理机制，推动标准化管理，确保符合公司质量体系、EHS及GMP相关要求。

Establish, optimize and implement operation-related processes, SOPs and management mechanisms, promote standardized management, and ensure compliance with the company quality system, EHS and applicable GMP requirements.

3、识别并解决运营过程中的异常、偏差，组织调查分析并推动纠正预防措施的制定、执行和跟踪关闭。

Identify and resolve abnormalities and deviations in operations, organize investigations and analysis, and drive the development, implementation and closure tracking of corrective and preventive actions.

4、负责运营团队人员管理，包括目标设定、任务分配、培训发展、绩效反馈及团队能力建设，提升团队执行力和协作效率。

Responsible for managing operations team members, including goal setting, task assignment, training and development, performance feedback and team capability building, to improve team execution and collaboration efficiency.

5、跨部门协调质量、生产、工程、仓储、供应链等相关团队，推动问题解决、计划衔接和运营目标达成。

Coordinate cross-functionally with Quality, Production, Engineering, Warehouse, Supply Chain and other relevant teams to drive issue resolution, plan alignment and achievement of operational objectives.

6、支持内部及外部GMP审计、客户审计和监管检查，负责运营相关问题的资料准备、整改措施制定及跟踪落实。

Support internal and external GMP audits, client audits and regulatory inspections, and be responsible for preparing operation-related materials, developing remediation actions and following up on implementation.

7、定期分析运营绩效指标，包括交付、效率、质量、成本及安全相关数据，推动持续改进、精益管理和运营效率提升。

Regularly analyze operational performance indicators, including delivery, efficiency, quality, cost and safety-related data, and drive continuous improvement, lean management and improvement of operational efficiency.

8.负责实验室的新建，确保符合法规的要求。

Responsible for establishing the laboratory and ensuring compliance with regulatory requirements.

9、完成上级安排的其他运营管理相关工作。

Complete other operation management-related tasks assigned by leadership.

任职要求：

Job Requirements:

1、本科及以上学历，制药工程、化学、生物工程、药学、管理或相关专业。

Bachelor’s degree or above in Pharmaceutical Engineering, Chemistry, Biological Engineering, Pharmacy, Management or related fields.

2、至少8年以上制药、生物医药或相关行业运营和质量相关工作经验，其中至少3年以上团队管理经验。

At least 8 years of experience in operations and quality-related work in the pharmaceutical, biopharmaceutical or related industries, including at least 3 years of team management experience.

3、熟悉制药运营管理、现场管理、偏差/CAPA、变更控制及质量体系要求。

Familiar with pharmaceutical operations management, shopfloor management, deviation/CAPA, change control and quality system requirements.

4、具备良好的业务全局观和计划管理能力，能够在质量、效率、成本和交付之间进行平衡并推动结果达成。

Good overall business perspective and planning management capability, with the ability to balance quality, efficiency, cost and delivery and drive results.

5、深入理解cGMP、数据完整性、EHS及合规管理原则，具备较强的质量意识和风险管理意识。

In-depth understanding of cGMP, data integrity, EHS and compliance management principles, with strong quality awareness and risk management awareness.

6、具备团队领导力、跨部门沟通协调能力、问题解决能力及持续改进/精益管理意识。

Demonstrated team leadership, cross-functional communication and coordination skills, problem-solving capability, and awareness of continuous improvement and lean management.

7、熟练使用Excel、PowerPoint等办公软件进行数据分析、绩效追踪和运营汇报；具备良好的数字化工具应用能力者优先。

Proficient in using office software such as Excel and PowerPoint for data analysis, performance tracking and operational reporting; candidates with good digital tool application skills are preferred.