Over 20 years Quality Assurance experience (GLP, GCPv, GCP, PV) for major pharmaceutical and contract research companies.  Senior Management and Global Leadership Team experience.
Experienced in conducting Investigator site, document, database, internal system, CRO, clinical laboratory, clinical pharmacology unit, pharmacovigilance and computer system validation audits.
Responsible for the determination of risk based Quality Assurance strategies for global and Asia-Pacific research and development operations.
Quality Assurance experience in over 30 countries with a focus on emerging markets in Asia-Pacific region. Completed secondments to Japan and China.
Completed British Association of Research Quality Assurance Postgraduate Diploma .
Specialties: Pharmaceutical development Quality Assurance auditing - GCP, Pharmacovigilance, CSV, GCPv and GLP.