Quality professional with extensive experience in GCP and ICH regulations for 15+ years. Proven ability to set up Clinical Quality Assurance functions in Biotech or Pharma companies and to head the Quality Department (GCP, QC and internal Quality Compliance). Hands-on experience of international auditing of clinical vendors (CROs and Clinical systems providers) as well as hosting FDA inspections. Industry experience includes the areas of Oncology, Endocrinology, Infectious Diseases, Neurology, Cardiology, Pediatrics with involvement in clinical study conduct of the following compounds: PLA-950 (Inhaled) Asthma, AAB-002 (IV) Alzheimer’s Disease, AAB-003 (IV) Alzheimer's Disease, ACC-002 (IM) Alzheimer's Disease, ILS-920 (IV) Stroke, NRI-470 (oral) Pain, SAM-760 (oral) Alzheimer’s Disease, inotuzumab ozogamicin (CMC-544) Indolent Non-Hodgkin’s Lymphoma, CME-881 (IV) Solid Tumors and the successful approvals of the drugs: Lenvima (DTC), Lenvima (RCC) and Halaven (STS). Developed corporate GCP quality program for domestic and global clinical operations, Created SOPs and tools for the conduct of Clinical study, including but not limited to cross-functional processes such as Data blinding, RBM, eTMF, Clinical Data Standards governance and up-versioning; Plan, organize, and perform audits of suppliers; hosted customer and supported regulatory audits. Conducted assessments of global clinical operations to identify business unit gaps against industry best practices, internal policies and regulatory requirements; Prepared and reviewed clinical research documents such as Study protocols, Study Quality Plan, Risk-based Monitoring Plan, CSR, ISS, ISE Reports. Lead quality and compliance improvement projects, Managed Quality team on-site and off-shore; applying unique background in clinical trial and computing.