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, and Oncology to ensure inspection readiness.
Role type
Associate Director, Clinical Program Quality
Builds
Inspection-ready clinical development programs across multiple business units
Domain
Pharmaceutical R&D / Clinical Research Quality
Deliverable
client delivery (inspection readiness and compliance)
Required skills
GCP compliance interpretation, risk-based audit strategy, inspection readiness management, root cause analysis, corrective and preventive action (CAPA) development, regulatory reporting, stakeholder influence, project management, technical writing
Preferred skills
Advanced degree, mentorship of managers, due diligence participation, process improvement
Technologies
N/A
Responsibilities
Provide GCP compliance expertise and training to development teams; define and implement risk-based audit strategies; lead health authority inspections and site preparation; investigate significant quality issues and breaches; analyze and report compliance metrics; escalate critical risks to senior management
Seniority
Senior, hands-on IC with strategic oversight
