Clinical Program Quality, Associate Director, R&D, China
Core
Oversees quality assurance for global and local clinical research programs in R&D, Plasma Derived Therapy, Vaccines, Oncology, and Marketed Products Development to ensure inspection readiness.
Role type
Associate Director, Clinical Program Quality (R&D)
Builds
Inspection-ready clinical research programs and compliant non-clinical study activities
Domain
Pharmaceutical R&D, Clinical Research, Regulatory Compliance
Required skills
GCP compliance interpretation, risk-based audit strategy, inspection readiness management, supplier quality oversight, corrective and preventive action (CAPA) development, regulatory guidance analysis, metrics reporting, stakeholder influence
Preferred skills
Advanced degree, NMPA/CFDI inspection leadership, domestic and international GLP regulations knowledge, drug development process expertise, technical writing, project management
Technologies
GCP, GLP, ICH guidelines, NMPA, CFDA, FDA, MHRA regulations
Responsibilities
Define and implement risk-based audit strategies; lead health authority inspections and site preparations; mentor Manager-level personnel; investigate significant quality issues and scientific misconduct; assess impact of audit findings on data integrity and safety; execute quality initiatives across internal and external groups; lead qualification assessments of external service providers; analyze and report program metrics; collaborate on cross-program compliance issues.
Seniority
Senior, hands-on IC with strategic thought partnership
