Director, Head of Quality and Senior/Lead GMP Inspector with more than 25 years at the interface Pharmaceutical Development and Pharmaceutical Production vs GMP Inspection. On both sides of the fence (>15 years industry & 10 years inspectorate). Extensive knowledge and proficient in regulatory guidelines including PIC/S Guidelines, US/FDA, EU/EMEA, UK/MHRA, and WHO. Successfully constructed a brown field CDMO and lead the site in obtaining GMP Certification for the manufacture of ATMPs (viral vector) for clinical applications which is the 1st in the Southeast Asia. Currently, constructing another brown field manufacturing facility for the manufacture of gene therapy for clinical trials.