丁香人才 > 职位招聘 >医药研发/制药生产招聘 >医药技术研发人员招聘 >上海医药技术研发人员招聘 >黄浦区医药技术研发人员招聘 >Senior Medical Quality Manager招聘

Senior Medical Quality Manager

礼来国际贸易(上海)有限公司 2017-01-19发布 2017-12-12截止
  • 学历要求: 本科
  • 英语要求: 熟练
  • 年龄要求: 不限
  • 专业要求: 临床医学
  • 工作年限: 五年以上
  • 月薪范围: 面议
  • 职位性质: 全职
  • 工作地点: 上海市黄浦区
  • 职称要求: 不限
  • 招聘人数: 若干

职位描述

Job Title: Senior Medical Quality Manager
Location: Shanghai

Purpose:
The purpose of the Medical Quality Manager role is to be a qualityadvocate to the designated team within affiliate medical unit who workswith the management and quality leadership to implement qualitymanagement system and drive continuous improvements.

Responsibilities:
1. Quality Mnagement
• Support risk assessment in area of responsibility to evaluate riskrelative to non-compliance with current regulation and companystandards, procedures & guidelines and contribute to risk mitigationplan
• Support the business in developing robust CAPA and monitors through toresolution for the following:
o Deviation management/Root Cause Investigation
o Audit responses management
o Inspection response management
• Reports issues through Notification to Management (NTM) as appropriate
• Participates in developing metrics & trends for area

2. Quality System
• Good knowledge of local regulations and applicable internationalguidelines
• Supports the development of global SOPs to ensure alignment with locallaws and regulations
• Supports MQS implementation and education of businesscustomers/partners
• Owner of quality related procedures at local level as assigned
• Be the initial point of consultation on MQS related question for areaof responsibility
• Communicates changes to local regulation to business customers/patners

3. Quality Control Checks
• Executes and documents quality control checks according to QualityControl plan. Discusses output of quality checks with business partnersand provides recommendations on corrections and CAPA
• Conducts process reviews based on quality data and trends
• Supports the business with the implementation of CAPA
• Conducts process reviews based on quality data and trends
• Provides consultations

4. Internal / External Collaborations
• Collaborates with other quality groups as appropriate and develops aquality network
o Shares key learning to drive simplification and replicate bestpractices.
o Actively participates in team and functional meetings

5. Inspection Readiness/Inspection Management
• Has awareness of inspection trends for area supported
• Involves in pre-inspection preparation activities in collaborationwith business customers/partners
• Prepares and educates internal and external businesscustomers/partners (incl investigator site staff) on inspectionmanagement
• Participates in inspection
• Contribute to inspection response management
• Actively participates in lessons learnt/shared learning

Minimum Qualification Requirements:
• Bachelor Degree and above in medical, clinical, scientific or healthrelated field
• At least 5 years above in clinical Trial monitoring and clincalproject management experience in CRO/MNC Pharma
• Knowledge of GCP regulations, guidelines and standards applicable tomedical research, including knowledge of Quality Systems applicable toall areas of medical research
• Knowledge of Quality Management Systems principles, includingpolicies, procedures and processes
• Global perspective
• Ability to separate critical from non-critical issues
• Ability to influence, negotiate and project manage
• Effective organization/self management skills
• Effective communication (written and spoken), negotiation andanalytical skills
 Excellent problem solving skills and initiative
 Proficient written and spoken English language skills
 Customer focus

联系人: 盛烨

地    址:上海市湖滨路222号企业天地一号楼16楼

美国礼来制药(Eli Lilly andCompany)是一家全球性的以研发为基础的医药公司,创立于1876年,总部位于美国印地安那州印第安纳波利斯市,业务遍及全球 125个国家和地区。礼来致力于为全人类提供以药物为基础的创新医疗保健方案,使人们生活得更长久、更健康、更有活力。

礼来制药与中国的渊源可以追溯到二十世纪初页。礼来于1918年来到中国,并将其第一个海外代表处设在上海,从而迈出了全球化的第一步。几经风雨历练,礼来于1993年重返中国。二十年多来,礼来本着“植根中国,造福中国”的理念,着力拓展在华业务,目前已经形成从研发、生产到商业运营的全产业链 ...详情

单位概况

礼来国际贸易(上海)有限公司
近两周应聘简历处理率:23%
制药/生物工程
医药企业 其他
1000~9999人
上海市湖滨路222号企业天地一号楼16楼
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