職位描述：
Quality Processes
Process, systems and documentation
? Support the local impact assessment of global R&D procedural documents and, if applicable, support development and management of associated local procedural documents
? Support to take oversight for local procedural documents in close collaboration with functional owners in China R&D/SAF and BRQC process and development
Training and knowledge management
? Support onboarding of new hires to provide general onboarding training package
? Coordinate local workshops to support QMS and compliance awareness, Lessons Learned, etc.
? Provide advice regarding SOP, system and GxP(GMP excluded) questions
? Coordinate the availability of local training curricula, if applicable, for China R&D/SAF in collaboration with local and global training partners such as regional Q&C, LOC e-University
? Support development of training materials for China R&D/SAF functional departments in collaboration with content owners.
Quality monitoring & compliance
? Support development of the Annual Quality Plan with remediation activities addressing compliance issues and risk signals
? Coordinate and/or perform QC checks and remediation actions specified in Annual Quality Plan. Monitor progress and effectiveness of remediation actions
? Support local and central business partners to facilitate (local) inspections and office audits as needed
? Support local and central business partners in timely CAPA setting and implementation
? On an ad hoc basis, perform activities such as On-Site Quality Monitoring and file checks
Data Quality, Metrics & Reporting
? Support disclosure of clinical data on local public web, if applicable (CT.gov excluded)
? Support to take oversight for system related data quality, e.g., TMS, CTMS
Regulatory Compliance
Local regulatory intelligence
? Support RA Quality representative to perform impact assessments of new/revised local regulations, guidance and standards
? Coordinate or support special investigation and issue remediation activities
Business Development
Vendor management
? Support local vendor assessments, if applicable
? Support activities related to annual DD update, certification and training of local vendors, if applicable
Business Quality
Management Review
? Support monitoring of compliance metrics, audit findings and issues (including appropriate escalation)
? Support LOC Management Review in collaboration with LOC quality partners
? Coordinate and/or participate in quality committee, if applicable
Others
? If applicable, support country specific quality management activities including but not limited to organizing cross-departmental quality meetings
