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