Job Description

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 needed
  • Vendor Quality OversightDevelop and execute Vendor Quality Plans; monitor vendor compliance.Drive remediation strategies for vendor quality issues a...

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