Summary Extensive strategic management development, deployment and execution supporting C-level, SVP and Sr. Management leading regulatory action remediation projects, coaching sponsors, key stakeholders and teams through containment, control, and compliance driving sustainability goals for Life Science companies in Biotechnology, Pharmaceuticals, Medical Device and Combination Products, addressing process improvement initiatives and with global regulatory citations for on-market products. Advanced Medicals Consortium, LLC Senior Director QA/RA March 2007 - Present Consulting: Ethicon, Cordis, International Bio-Resources (IBR), Talecris Biotherapeutics, Renovar, Tecan, SeetTek, Symbios Medicals, American Red Cross, 5D Information Systems, eTherapeutics, Life Technologies/Invitrogen, Roche Diagnostics, Beckman Coulter, Fisher & Paykel Healthcare, Anesthesia Safety Products, Exact Sciences, DePuySynthes (JnJ), Amgen, Ethicon (JnJ) & IVD Diagnostics Manufacturer, Thermo Fisher Scientific, Patheon, Stryker/Howmedica. * Site Quality and Compliance lead, Interim Director QARA and CAPA Manager for IVD Manufacturer - internal/external remediation

Highlights:

• Director Quality Assurance
• Director Regulatory Affairs
• Senior Project Manager
• Director PMO
• ISO
• Software
• Software Development
• Quality Compliance
• Director QARA