Mission: Empower Business, Suppy, Compliance Aspirations and PredicabilityTested leader, that assembles SME teams from across the globe, customizes and leads effective Integrative Risk-Based GMP/GDP Assurance Audits (IIA) and advisory services for Internal Audit and Operational risks. The breath has included, Due Diligence, Acquistions, Enterprise Risks, Assessment of GMP Audit Programs for effectiveness, TPRM-Governance & CMOs, For Cause/Recall, Remediation Verification, including post leading consultant organizations, Inspection Readiness, Mock PAI, Sterile/Annex 1 assessment for US market, logistics and, Global Business unit Risks. Assessed and drove mitigations for the global compounding program. Proficient and practical application of a broad array of National (MHRA, FDA, EMA, (e.g. Annex 1,) , COFEPRIS, ANVISA, PDMA, SFDA, EDA, Health Canada, FDA etc.) and international standards (ICH, ISO, PICs, WHO, ISO, Pharmacopeias). Experience across diverse portfolios within more than 30 countries; the Americas, EU, Asia Pac, Middle East and North Africa for clinical and commercial products. SME in the application and assessment of multiple Risk Based tools, CMO Lifecycle., Investigations, Cold Chain, and in the assessment of Quality Managment Maturity, Risk Maturity and Cultural indicators. Develop and utilize practical audit and operational standards for niche areas such as compounding to accelerate clinical trials, ATMP, ADC-Potent-Oncology, and Fast Bio Track Assets. Breadth of experiences includes Bio (cell bank, bulk, fill), Nuclear-Isotope, API's, Rx/Sterile/ViiV, Cx, Medical Devices, combination products, Vx Suppliers and ATM, from early clinical phases, commercial and through the entire global supply chain (E2E). Integrate evaluations to Enterprise Risks and Strategy. Negotiate Operational Excellence, Efficiencies, and system-based Root Cause CAPAs with multiple levels of management and functions to the established Risk Appetite. Summary:Provide a Nexus approach drawn from; Business Education, with experiences in; Start up Manufacturing of clinical materials, through PAI/GMP inspections and commercial supply and a wide breadth of E2E Global Assurance/Quality Experiences.Member: Society of Corporate Compliance and Ethics (SCCE), Actively Pursuing CCEP-I/ Certified Compliance & Ethics Professional-Internati