Provide executive QA oversight of Clinical Pharmacology Units (CPUs), ensuring inspection readiness and compliance with GCP, GMP, and applicable regulatory standards
Oversee QA frameworks governing GMP pharmacy operations within each CPU, including investigational product (IP) manufacturing, handling, labeling, storage, and accountability
Ensure robust controls across pharmacy processes, including chain of custody, temperature control, documentation, and reconciliation practices
Drive standardization and continuous improvement of CPU and GMP pharmacy quality systems, ensuring alignment across global sites
Support readiness for regulatory inspections and sponsor audits related to CPU and
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