Sophia Zhang

1. Lead HA inspections, including Pre-approval NMPA GCP inspection at Site and Vendors. Currently leading GVP inspection preparation. 2. Perform Supplier Qualification Assessment (SQA) for Vendors support GCP, GPvP activities. Partner with Global Auditor team, to conduct Vendor audit, support the response review and CAPA follow up. 3. Perform Site visit for inspection readiness. 4. Drive Quality Issue Management for any deviations in GCP area and GPvP area, ensure robust investigation, CAPA plans in place. 5. Conduct Quality Risk Assessment for GCP and GPvP areas in country level. 6. Maintain local QMS system, lead Regulatory, GOP gap assessment, and work as QA review for local SOP periodic review and updating. 7. Support and monitor implementation of the local Quality Plan (QP) deliverables related to GCP and PV areas, ensuring alignment with the applicable global QP chapters wherever possible. 8. Lead country level Key Quality Indicators (KQIs) monitoring on PV and GCP activates, perform regular trending analysis in Quality Issue, HA inspections, and audits, to proactively identify potential quality risk. Ensure any identified trends/risks related to PV or GCP are communicated in the country Quality Review Board, and addressed in a timely manner. 9. Work as GPvP QA consultant support PV functions for daily PV activities, PV regulatory gap assessment, Patient Orientated Projects, and Social Medial and Digital projects, to ensure GPvP compliance. 10. Support Medical Affair on Post Approval Research(Non-interventional Study), IIT, MAP, and PSDS projects. 11. Provide oversight on Country Safety Label Change to ensure the Regulatory compliance and Global Procedure compliance.

1.Perform internal audits for all functional departments, including project management, Data management, and laboratory operation departments, etc., according to ICH-GCP, GCLP regulatory, quality standards and CLS policies and procedures. 2. Host sponsor audits, and follow up response review and delivery. 3. Conduct vendor audits according to regulatory requirement. 4. Act as a consultant for project department for clinical trial project quality issue resolution. 5. Lead or support regulatory inspections, including NMPA, HGRAC, CAP, ISO 15189 regulatory inspections. Support response completing and submitting. 6. Executes existing interpretation of regulatory requirements (ICH- GCP, GCLP, CAP, ISO 15189, etc). 7. Deliver regulatory, procedure, and policy training to operational team. 8. Maintain QMS, collect and perform Quality Metrics review yearly. 9. Maintain Sop administration. Deliver training to QA delegate to ensure Document control and Sops readiness. 10. Attend Investigator Meeting for Clinical Trial Project initiation, and provide Covance training materials for investigator sites. 11. Some experience of GLP project review.

Central laboratory services for clinical project testing, which followed GCP, and GCLP guidance. 1.Provide leadership to department staff through mentoring and coaching. Ensure Policy, SOP and other provisions of company are well followed. Engage people management by competency review and performance evaluation. 2.Oversee training activities to ensure clinical assay accuracy, quality and consistency. Ensure area personnel are appropriately trained to support on-going patient testing. 3.Be charge of new assay validations, instruments, and equipment qualification. Perform periodic Review and approval of laboratory quality control program records(quality control data, reagent log, instrument log) 4.Yellow belt of Six Sigma, lead some process improvement projects. 5.Participate in global SOP review. Serve as site resource to provide guidance to global sites for implementation of new processes/changes, and facilitate resolution of global issues. 6.Act as consultant to the internal customers, and clients in all technical/scientific facets relating to laboratory activity.  7. Participate in internal Audit, sponsor audit, NMPA inspection, CAP accreditation, and ISO15189 accreditation. Take charge of Rout Cause investigation, Containment Action, Corrective action and Preventive Action (CAPA).