SUMMARY OF QUALIFICATIONS
Accomplished Validation and Quality Assurance Leader with expertise in providing global oversight and leadership to validation and quality engineers in all aspects of GXP software validation activities including requirement reviews, test methodology design, integration testing and software verification. Candidate with a strong entrepreneurial instinct combining in depth technical skills and a strong reputation for developing, leading and motivating cross-functional teams at all levels. Prior hands-on experience include: Software Quality Assurance Engineer, Software Engineer, Software Test Engineer, and Product Validation Liaison.
PROFESSIONAL EXPERIENCE
IBM Watson Health, Raleigh, NC 2016-present
Senior Validation Engineer and Team Lead, GXP platform Contractor
Worked within the Watson Platform for Health and Watson Patient Safety projects
Focused providing (Rational Quality Management) RQM solutions to the Validation Team
Lesioned between the Validation team and the RQM support team.
Collaborated with product engineering to increase quality of Software applications and supporting documentation released
Results included: Work Instructions, Team process training, GXP compliant documentation, all in support of product platform client delivery
PAREXEL INTERNATIONAL, Raleigh, NC 2014-2016
Senior Validation Consultant, IT
Application Testing of a bespoke Virtual Clinical Adjudication System
Collaborated with team in creating and executing test cases.
Perceptive Informatics of PAREXEL INTERNATIONAL, Billerica, MA 2007-2014
Senior Manager, Product Acceptance
Worked within the eClinical Platform Solutions (eCPS) department
Focused on methodologies to decrease non billable product acceptance testing cost
Collaborated with product engineering to increase quality of Software applications released to eCPS
Results included: new engineering exit criteria requirements that incorporated end-to-end functional integration testing and performed user acceptance test on releases prior to client delivery
Solved validation resourcing challenges by expanding the validation team globally, including Europe, Russia and India
Managed global team without compromising the quality or productivity of staff
Created cross operations collaboration among validation managers and directors (including engineering and clinical operations teams) to stream line the validation processes across organizations
Grew validation team from 3 to 5 Engineers, including one off shore team member;
Created processes to stream line the validation workflow which resulted in an increase of billability and decrease in non-billable task
Ensured team maintained minimum 80% billability
PhaseForward, Inc. Waltham, MA 2000-2006
Technical Consultant – Product Validation
Created and executed validation scripts for the customizable Web-based applications: clinical coding and dictionary management, InForm CRF submit
Conducted client training sessions for both “Testing an Inform Trial” and “Product training of CRF Submit”
Supported InFORM software trainers for client product end-user training sessions
Helped build a quality assurance team to perform end user testing of a web-based electronic data capture (EDC) system for clinical trials, InForm
Lead a team of 7 software testers allocated resources
Kronos Inc., Waltham, MA 1997-2000
Software Quality Assurance Engineer
Created automated test scripts using WinRunner to test data entry for time and attendance system
Conducted suite of end user tests prior to software release to ensure software stability
Fidelity Investment, Marlboro, MA 1996-1997
Software Test Engineer
Created test plans and cases for GUI testing of an upgrade to a MS-Windows client/server environmental survey data base used by environment engineer auditors
Raytheon, Marlboro, MA 1987-1995
Software Quality Engineer
Participated in steps to become 2167A compliant
Responsible for project audits, ensured compliance of software to customer requirements and applicable military standards and tested software written for a satellite communication system
EDUCATION
Bachelor of Science, Computer Sciences
Virginia Polytechnic Institute and State University, Blacksburg, VA 1984
OTHER INFORMATION
Technologies: XML, SQL, Microsoft Office (Word, Excel, Powerpoint, Access), Oracle, Visio, UNIX, Winrunner, ClearCase
Clinical Applications: InForm (EDC Product), CRF Submit (EDC Product), DataLabs (EDC Product), RTSM (IVR product), CTMS (Clinical Trial Management System)