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Software Validation Lead

Location:
Raleigh, NC
Posted:
October 08, 2018

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Resume:

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)



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