Commercial Quality Business Excellence

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Overall purpose of job工作的总体目的

The Commercial Quality Business Excellence is responsible for the quality of and meeting the applicable requirements for the products that J&J IM China markets and/or the products under J&J company which take responsibility by J&J IM China CQ team and quality system maintenance.

商务质量卓越运营负责J&J IM中国市场销售的产品和/或JJIM中国CQ团队负责的J&J公司旗下产品的质量并满足适用要求以及质量体系维护

He/she is also taking responsibility to ensure compliance with the local laws/regulations and the elements of the Johnson & Johnson Quality Policy that are applicable to the GxP activities JJIM this role he/she has defined authority and responsibility for ensuring that quality system and processes as are described in the Commercial Quality Manual(CQM) are implemented maintained and is dedicated to continuous improvement thereof.

他/她还负责确保遵守当地法律/法规以及适用于JJIM开展的GxP活动的强生质量政策的要素在此职位上他/她确定了权力和责任以确保商业质量手册CQM中所述的质量体系和流程得到实施维护并致力于持续改进

General Responsibilities of Quality System: 质量体系的一般职责

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.).

通过转换适用要求法律法规和强生质量政策标准和程序等要素建立和维护质量体系

Prepare update train and implement global CQ/local LOC procedures in accordance with local GxP CQ manual and J&J requirements.

根据当地GxPCQ手册和强生要求准备更新培训和实施全球CQ/当地LOC程序

Ensure regulation management system is compliant and consistent with applicable J&J policies global and sector standards (Pharma and Consumer) and global and regional processes (as applicable) including implementation of separate segment escalation and governance.

确保监管管理体系符合适用的强生政策全球和行业标准制药和消费者以及全球和区域流程如适用包括实施单独的部门升级和治理

Events and Deviation Management: 事件和偏差管理

Ensure that all events and deviations for Janssen China products and critical systems are timely handled documented investigated for route cause and assessed for its impact on product quality and safety.

确保及时处理记录调查杨森中国产品和关键系统的所有事件和偏差并评估其对产品质量和安全的影响

Ensure appropriate corrective actions and preventive Actions (CAPA) are taken to mitigate the effect of an event/deviation as well as to prevent recurrence in the future

确保采取适当的纠正措施和预防措施CAPA以减轻事件/偏差的影响并防止将来再次发生

Maintain and keep updating for the intracompany quality agreement to drive LOC related systems update and be consistent with agreement requirements.

维护并不断更新公司内部质量协议以推动LOC相关系统的更新并与协议要求保持一致

Ensure related quality record retention according to J&J requirements.

确保按照强生公司的要求保留相关质量记录

Prepare execute and follow up for the inspection as system SME.

作为系统SME准备执行和跟进检查

Ensure appropriate internal and external change control systems are followed.

确保遵循适当的内部和外部变更控制系统

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 CQM.

根据CQM中概述的上报程序通知丽水作业公司商业质量负责人和其他受影响的利益相关者并让他们了解有关产品质量安全和/或IT合规性的任何实质性问题

Provide quality insight according to statistics data analysis.

根据统计数据分析提供质量洞察

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

领导和升级关键产品问题并及时支持召回/现场行动

Other works assigned by line manager.

直线经理交办的其他工作

Quality and Operations: 质量和运营

Responsible for China LOC Purchasing Control management as CQ contact to work together with LOC cross functional team and global SQM team to ensure local regulations and J&J standards and SOP requirements compliance.

负责中国LOC采购管控的质量管理作为CQ联络人与当地跨部门团队及全球SQM团队协同合作确保符合当地法规强生标准及标准操作程序要求

经销商的管理包括分销商的选择/资格/批准分销商的质量协议分销商的监控和ADL维护分销商审计计划/现场审计/CAPA跟进确保符合当地法规强生标准和SOP要求

Responsible for testing method qualification related to import products routine testing tracking and handling of technical issues. Collaborate closely with AD/RA team and external business partners to support new product launch post-market product testing method changes and product supply.

负责进口检验相关的方法学确认以及日常检验追踪和相关技术问题的处理与AD/RA团队和外部业务伙伴密切合作支持新产品上市/方法许变更以及产品的供应

Responsible for import products traceability including connection with internal and external team to maintaining master data in system e-codes download /upload product traceability issue handling to ensure meeting traceability related regulations and J&J standards and SOP requirements.

负责进口成品的可追溯性包括与内部和外团队联系维护系统中的主数据追溯码下载/上传产品可追溯性问题处理以确保符合可追溯性相关法规和强生标准及SOP要求

Controlled Substances Security Management: 受控物质安全管理

Ensure that daily operations adhere to the requirements of controlled substances drug safety management system and associated documents.

确保日常操作符合特殊药品安全管理制度及相关文件要求

As personnel of controlled substances drug safety management agency perform one or more of the following main responsibilities:

作为特殊药品安全管理机构人员履行以下主要职责

Review the legal qualifications of distributors including the identification documents of procurement personnel whenever a new distributor is added or there are changes to the distributors master data.

新增经销商或经销商主数据变动时负责对购买方的合法资质以及购买方采购人员的身份证明进行审核

Review the qualifications and safety management capabilities of transportation service providers including conducting new vendor audits and periodic audits.

负责对运输单位的资质和安全管理能力进行审核包括新增承运商审计以及承运商周期性的审计

ORGANIZATIONAL LEADERSHIP: 组织领导

Leverage internal and external resources to develop and advance team members.

利用内部和外部资源培养和提升团队成员

Foster a culture of inclusion and belonging increasing engagement productivity and innovation.

培养包容和归属感文化提高参与度生产力和创新能力

Required Qualification and Core Competencies所需资格和核心竞争力

Required Qualification所需资格

1. Certifications:证书

Bachelors degree or higher of Pharmaceutical Chemical Biology or a related scientific discipline.

药学化学生物学或相关学科本科以上学历

2. Experience:经验

At least 5-10 years experience in the Pharmaceutical or related industry ideally with a mix of GSP quality management supply chain experiences on product import & release product traceability management.

至少5-10年的制药或相关行业工作经验最好具有GSP质量管理产品进口和发布供应链经验以及产品可追溯性管理经验

3. Language:语言

Full competency in local language and a working knowledge of English.

完全掌握当地语言和英语工作知识

4. Specific systems:特殊系统

Good knowledge of Customs system import filing process import test tracking process.

熟悉海关系统进口备案流程进口测试跟踪流程

Good knowledge of SAP quality module design and operation.

熟悉SAP质量模块的设计和操作

Core Competencies核心竞争力

1. Specific knowledge 专业知识领域

Knowledge and full understanding of the J&J Quality Policy and the procedures and processes outlined in Quality Manual

了解并充分理解强生质量政策以及质量手册中概述的程序和流程

Up-to-date knowledge of relevant pharmaceutical legislation and GxP

了解相关药品法规和GxP的最新知识

Knowledge and full understanding of China GSP regulation traceability requirements and product import & testing process

了解并充分理解中国GSP法规可追溯性要求以及产品进口和测试流程

2. Personal and interpersonal skills / Leadership skills个人能力/领导能力

Good command in English both in writing and verbally

良好的英语书面和口头表达能力

Strategic thinking is required with a focus on process improvement and optimization.

需要战略思维重点是流程改进和优化

Demonstrates strong project management skills with the ability to manage the multiple tasks.

表现出强大的项目管理技能能够管理多项任务

Expert knowledge of Microsoft software and presentation

精通微软软件和演示文稿

Good analytical thinking and problem-solving skill

良好的分析思维和解决问题的能力

3. Personal attitude and mindset个人态度和心态

Communicative / Motivator / Negotiator / assertive person having impact

具有影响力的沟通者/激励者/谈判者/自信的人

Showing a high sense of responsibility regarding professional activities

对职业活动表现出高度的责任感

Positive mindset to work together with stakeholders and strong quality sense.

与利益相关者合作的积极心态和强烈的质量意识

Required Skills:

Preferred Skills: