Paul W. Hamby

Experience

1. Senior Director, Us Regulatory Compliance

   IQVIA

   Jul 1997 — Present · Atlanta, GA, US

   SENIOR DIRECTOR, US REGULATORY COMPLIANCE (October 2012 – Present)• Lead the 100+ employee US Regulatory Compliance (former BuzzeoPDMA) organization, directing all day to day operational activities and functions.• Lead delivery of a diverse portfolio of DEA, FDA, and state support services that assist Life Science companies strengthen and enhance federal and state regulatory compliance including Prescription Drug Marketing Act (PDMA) drug sample accountability, state laws including state licensing, computer systems validation, and DEA and FDA compliance. • Subject Matter Expert in the PDMA, FDA’s Title 21 CFR Parts 11 and 203, and the DEA’s Suspicious Order Monitoring (SOM) requirements.SENIOR DIRECTOR, REGULATORY CONSULTING SERVICES (May 2012 – October 2012);DIRECTOR, REGULATORY CONSULTING SERVICES (May 2007 – May 2012)• Promoted to assume leadership of BuzzeoPDMA’s State Services teams.• Continued to lead operations that provide regulatory consulting services. DIRECTOR, CONSULTING AND VALIDATION SERVICES (January 2007 – May 2007)• Promoted to lead the operations that provide regulatory consulting services for DEA, FDA, and VAWD compliance.• Continued to lead the Computer Systems Validation Services testing function.DIRECTOR, VALIDATION SERVICES (April 2005 – December 2006);MANAGER, VALIDATION SERVICES (June 2002 – April 2005)• Promoted into new role, transforming internal Quality Assurance overhead cost center into revenue-generating, external testing service. QUALITY ASSURANCE MANAGER (April – June 2002)• Promoted into management position with responsibility for twelve employees in the Quality Assurance organization leading 50+ testing projects. SENIOR QA ENGINEER (July 1997 – April Served as Team Leader for 10+ Quality Assurance / Quality Control software testing projects, leading and actively participating in acceptance, functional, performance, and system testing efforts.

Education

• Clemson University

  BS, Computer Engineering

  1986 — 1990

Skills

• Pharmaceutical Industry
• Business Process Improvement
• Sop
• Fda
• State Licensing
• Cross-Functional Team Leadership
• Integration
• Dea
• Databases
• Outsourcing
• Leadership
• Process Improvement
• Business Analysis
• Requirements Analysis
• Validation
• Management
• Pdma
• Business Intelligence
• Project Planning
• Business Process
• Quality Management
• Software Documentation
• Sdlc
• 21 Cfr Part 11
• IT Strategy
• Software Quality Assurance
• Project Management
• Saas
• Computer System Validation
• Gamp
• Software Project Management
• Testing
• Sharepoint
• Vendor Management
• Crm
• Quality Assurance