GCP/GLP inspection and quality leadership for regulated research
Dr. Alexandru Sirbu is a senior GxP quality and regulatory expert with international inspection, audit, and quality systems experience across clinical research, laboratories, sponsors, CROs, IRBs, and regulatory authority programs.
Dr. Alexandru Sirbu
GCP & GLP Expert | Quality Assurance Lead
- Former EMA-certified GCP and GLP Inspector
- WHO-appointed GCP/GLP Inspector
- Global audit and inspection experience across CROs, sponsors, laboratories, and IRBs
Appointment
Professional profile
Dr. Sirbu has served as a GCP/GLP inspector and auditor in international and national regulatory contexts, including work connected to EMA inspector groups and WHO inspection activities. His background covers inspection readiness, clinical quality assurance, HRPP/IRB oversight, AAHRPP alignment, SOP and QMS development, CAPA, data integrity, and regulatory training.
He has led and supported audits, gap assessments, protocol deviation investigations, CAPA planning, quality dashboards, and inspection preparation across complex research environments. His experience also includes strategic quality leadership for clinical research programs, including HRPP governance, centralized oversight committees, and system-wide quality management implementation.
Core expertise
GCP and GLP inspections, clinical QA audits, inspection readiness, HRPP and AAHRPP readiness, QMS implementation, SOP development, CAPA and remediation, data integrity, vendor oversight, trial transparency, and regulatory training.
International experience
Former EMA-certified GCP/GLP Inspector, former Ministry of Health GCP/GLP Inspector, and WHO-appointed GCP/GLP inspector with inspection and audit experience across Europe, the Middle East, Asia, CROs, sponsors, national authorities, laboratories, and research institutions.