Senior Medical Quality Manager

Job Title: Senior Medical Quality Manager
Location: Shanghai

Purpose:
The purpose of the Medical Quality Manager role is to be a qualityadvocate to the designate******** within affiliate medical unit whoworks with the management an******** leadership to implement qualitymanagement system an******** continuous improvements.

Responsibilitie********
1. Quality Mnagement
• Support risk assessment in area of responsibility to evaluate riskrelative to non-compliance with current regulation an********stan******** procedures & guidelines an******** to risk mitigationplan
• Support the business in developing robust CAPA an******** through toresolution for the following:
o Deviation managemen******** 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
• Goo******** of local regulations an******** international guidelines
• Supports the development of global SOPs to ensure alignment with locallaws an********
• Supports MQS implementation an******** of business customer********
• Owner of quality relate******** at local level as assigned
• Be the initial point of consultation on MQS relate******** for area ofresponsibility
• Communicates changes to local regulation to business customer********

3. Quality Control Checks
• Executes an******** quality control checks according to QualityControl plan. Discusses output of quality checks with business partnersan******** recommendations on corrections an********
• Conducts process reviews base******** quality data an********
• Supports the business with the implementation of CAPA
• Conducts process reviews base******** quality data an********
• Provides consultations

4. Internal / External Collaborations
• Collaborates with other quality groups as appropriate an******** aquality network
o Shares key learning to drive simplification an******** best practices.
o Actively participates in team an******** meetings

5. Inspection Readine******** Management
• Has awareness of inspection trends for area supported
• Involves in pre-inspection preparation activities in collaborationwith business customer********
• Prepares an******** internal an******** business customer********(incl investigator site staff) on inspection management
• Participates in inspection
• Contribute to inspection response management
• Actively participates in lessons learn******** learning

Minimum Qualification Requiremen********
• Bachelor Degree an******** in me******** cl******** scientific orhealth relate********
• At least 5 years above in clinical Trial monitoring an******** projectmanagement experience in CRO/MNC Pharma
• Knowledge of GCP regulat******** guidelines an******** applicable tomedical research, including knowledge of Quality Systems applicable toall areas of medical research
• Knowledge of Quality Management Systems pr******** includingpol******** procedures an********
• Global perspective
• Ability to separate critical from non-critical issues
• Ability to ******** negotiate an******** manage
• Effective organization/self management skills
• Effective communication (written an********), negotiation an********skills
 Excellent problem solving skills an********
 Proficient written an******** English language skills
 Customer focus