Purpose:
Ensure implementation and oversight of the GCP Quality Management System (QMS) for clinical development activities in China, aligned with global standards and regulatory requirements, while driving digital and AI-related initiatives.
Key Responsibilities
Quality Management & ComplianceImplement GCP QMS strategy locally; maintain Level 1 GCP quality documents.Ensure consistency with regulatory expectations through planning, monitoring, and continuous improvement.Act as Subject Matter Expert (SME) and point-of-contact for clinical quality requirements, promoting Quality-by-Design principles.Inspection & Audit ReadinessEnsure inspection readiness and manage regulatory inspections with cross function.Serve as primary contact for audit response management as neededVendor Quality OversightDevelop and execute Vendor Quality Plans; monitor vendor compliance.Drive remediation strategies for vendor quality issues a...