Commercial Quality Manager

• • 全面负责产品质量管理工作，独立履行职责，在公司内部对产品质量管理具有裁决权

Fully responsible for product quality management, perform duties independently, make decision for product quality management

• • 组织建立和完善公司经营质量管理体现，对该体系进行监控，确保其有效运行。

Organize the establishment and improvement of the company's business quality management system, monitor the system and ensure its effective operation

• • 通过符合相应要求（法律、法规和强生质量政策、标准和程序的要素等）来建立和维护质量体系。

Establishing and maintaining Quality System via transposition of the applicable requirements (laws, regulations and the elements of the J&J quality policy, standards and procedures etc.).

• • 定期对公司经营质量管理体系进行监督检查，检查结果直接上报所在地食品药品监督部门。

Conduct regular supervision and inspection of the company's business quality management system, and report the inspection results directly to HA

• • 定期在质量管理体系关键要素发生重大变化时，组织开展内审。

Organize internal audits on a regular basis when key elements of the quality management system change significantly

• • 对公司购进、储存、销售、运输过程中涉及的可能影响产品质量等问题行使决定权。

Make decision on the company's purchase, storage, sales, transportation and other issues that may affect product quality.

• • 对公司的购销资质证明文件、产品标签说明书、合同、票据、汇款单位、产品来源及真伪等进行审查和甄别。

Review and identify the purchase and sales qualification documents, product label instructions, contracts, bills, remittance units, product sources and authenticity, etc

• • 审核质量管理程序，组织对各项质量管理程序执行情况的检查与考核。

Audit quality management procedures, conduct inspection and assessment of the implementation of quality management procedures

• • 负责对首营企业和首营品种的质量审批。

Quality approval for first sale enterprise and first sale product

• • 研究和确定公司质量管理工作的重大问题。

Research and identify major issues of quality management。

• • 负责对计算机系统权限的审批。

Approval of computer system permissions

• • 负责验证工作的监督、指导、协调与审批。

Responsible for the supervision, guidance, coordination and approval of validation work

• • 根据质量手册中概述的上报程序，通知LOC商业质量负责人和其他受影响利益相关者有关产品质量、安全性和/或IT合规性的任何实质性问题。

Notify and engage LOC Head of Commercial Quality and other affected stakeholders with any substantive concerns regarding product quality, safety and/or IT compliance, as per the Escalation procedures outlined in Quality Manual.

• • 根据统计数据分析，向经理和其他利益相关者提供质量洞察力。

Provide quality insight to manager and other stakeholders according to statistics data analysis.

• • 领导并上报关键产品问题，并及时支持召回/现场行动。

Lead and escalate critical product issue and support the recall/field actions in timely manner.

• • 质量负责人指定的其他工作。

Other works assign by Head of Quality.