Senior Medical Quality Manager

面议 上海黄浦区 6-10年 本科 全职
礼来国际贸易(上海)有限公司 2017-08-23 更新 2017-12-12 截止

Senior Medical Quality Manager

Job Title: Senior Medical Quality Manager
Location: Shanghai

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.

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
  • 临床医学

  • 本科

  • 6-10年


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