30 combined years of experience in Software/Technical Quality Assurance/Compliance. 20 years of experience within management (i.e.,Software Quality Assurance/Validation Manager/Associate Director). 15 years of compliance/auditing experience within regulatory environment(i.e., Pharmaceutical, Medical Device). 3 years of experience in Prescription Medicines, PDMA compliance, Sunshine Act, Sample Management4 years of experience in Cloud Computing implementation and risk assessments (e.g., SaaS, IaaS and PaaS)Areas of expertise include: Auditing, Validation, Compliance, Design Controls, Requirements Analysis, and Hardware/Software Testing.Specialties: •Quality Models/Standards/Regulations: ISO9000 (Quality Management Principles), SEI/CMM, FDA 21 CFR Part 820 (cGMP), 21 CFR Part 11, 21 CFR Part 211(cGMP), GCPs, 21 CFR Part 58 (GLP), UL 1069, FCC Part 15, ISO 12207 (Life Cycle Processes), Annex 11, IEEE, ANSI/ASQC Z1.4, Sarbanes Oxley (SOX)•Management Audits: Internal Audits, Audit Checklists, Audit Reports, CAPAs, Failure Investigations/Root Cause Analysis, Cause and Effect Graphs, Pareto ChartsFrameworks: ITIL v3 Foundation