Direct Companywide Quality Systems in accordance with ISO standards and GxP, Manage Software Quality for development, release and maintenance (SDLC/SLC) for Enterprise / Cloud / SaaS andMobile Applications in accordance with GAMP5 CSV/Annex 11,PIC/S, HIPAA and SOX. Manage Internal and External Audits, RFP/Vendor Qualification, Training Program Management, CAPA and Design Control.

Revamped and standardized Quality Policy/Manual, SOPs and Lifecycle Processes (Agile/Iterative). Certified Auditor for Quality and Information Systems. Active membership -ASQ/ISACA/ISPE. Expertise in managing ISO/COBIT5/HIPAA/SOX assessments and remediation. Keen interest in Cyber security, cloud compliance, hosting provider qualification and SLAs/data center compliance audits and infrastructure qualification. Strong expertise auditing supplier and vendor sites.
Proficient in SAP, Supply Chain Track and Trace / Serialization, GS1/EPCIS/DSCSA compliance, MES for clinical materials, Manufacturing Control Systems (DCS/SCADA), LIMS, Oracle Clinical and Warehouse Management Systems.