SUMMARY

An accomplished results oriented leader with 28 years IT project management in architecting and delivering technical solutions. Possess extensive leadership experience across multiple industries and a number of global enterprise systems driving the onsite and off shore teams to success, on time and on budget. As a proven professional with unparalleled collective experience, a seasoned veteran, mentor and an integral member of project management, partnering with stakeholders and cross - functional teams to facilitate solutions throughout the entire SDLC.

EXPERIENCE

Confidential

Validation / Quality Assurance Consultant

• Andrada Consulting utilizes Validation and Quality Assurance best practices to provide client project support, filling in the gaps to ensure a smooth execution and successful implementation.
• Validation / Quality Assurance project planning and execution
• Procedure and protocol development / consultation
• Validation / Quality Assurance documentation development
• Systems Audits for regulatory compliance
• Third-party review of customer documentation / project materials

Program Validation Manager

• The purpose of the SAP Serialization Project was to incorporate product serialization into the client's Supply Chain. This included developing a SAP ERP, AII, PI and OER system to serialize the pharmaceutical products from the time of manufacturing to end client delivery, a Tracked and Trace system and an ePedigree system.
• Identified and created all three sets of Validation deliverables required for all three phases of the SAP Serialization project using the GAMP methodology
• Quantified and authored the entire Validation documents i.e., Validation Plan, Validation Summary, IQ/OQ/PQ Protocol/Summary and negotiated final approval of all the Validation documents with the key stakeholders
• Functioned as the Validation Lead and coordinator to execute system integration Validation efforts along with the client, 3PL, CMO and manufacturing counterparts
• Liaison to the QA-CSV to ensure Validation compliance and negotiated Validation documents approvals
• Delivered approved Validation documentation to mark the successful delivery of the SAP Serialization project on time and on budget
• Validation Lead: Ensured compliance with the client's Validation procedures and protocols, served as Validation SME and created mitigation steps and resolved any validation risks/issues and reviewer of all Validation deliverables
• Developed MS PowerPoint Validation templates to deliver weekly progress reports on the validation efforts, validation metrics and mitigation steps for any outstanding risks/issues for the PMO, validation, business and system integration meetings
• Conducted separate weekly Validation status meetings with QA-CSV and system integrator counterparts to review each member's Validation progress and identify and mitigate any outstanding Validation issues/risks
• Kept PM abreast on Validation and project status, identified risk/issues and implemented mitigation strategies
• Defined and implemented the RACI Roles and Responsibilities matrix for the project
• Successfully created, implemented, maintained and reported on a MS Project Plan of the Validation tasks and deliverables, which resulted in on time delivery and on budget
• Established and trained the four on-site and ten off-shore team members to complete Validation deliverables i.e., IQ/OQ/PQ, URS and FRS
• Functioned in the pharmaceutical regulated Validation space, GMP, GCP and GxP

Confidential

Agile Tester

• The purpose of the web-based Adobe TRACE Tracking Resource Allocation and Contract Execution application was to provide the Consulting division a system for planning the resource needs of a contract or other types of work, that also takes into consideration resources' time off and training activities. Based on the contracts hours and rates that are associated with an assignment, Consulting was also able to provide their Revenue Forecast. The application was developed using Scrum and the Agile software development methodology. The application was developed in Adobe Flash Builder 4.6, Eclipse, Juno and JBoss 5.1 with an Oracle backend.
• Developed and implemented the Agile testing strategy that was utilized for all Sprints
• Created test cases for each story and executed test scripts during the Cycle Testing, Acceptance Testing and Platform Testing
• Defined, planned and executed the testing tasks, schedule and resources for each Agile testing cycle
• Conducted daily and ad-hoc meetings with developers to discuss defects, new functionality, code delivery and code testability
• Created and reported testing status, metrics and mitigation strategies in the Daily Scrum meetings
• Contributed in Sprint Planning Meetings, Sprint Review meetings and Sprint Retrospective to provide testing perspective and input on improving each Agile testing cycle
• Utilized Rally to enter testing artifacts, generate testing status reports and testing metrics which were employed in the subsequent Sprint meetings

Confidential

Validation / Quality Assurance Lead

• AEGIS Adverse Event Global Information System is a cross-divisional program that provides harmonized tools and processes for adverse event reporting and analysis in the Pharmacovigilance space. The AEGIS Upgrade 8.0.0 project migrated from a client/server system to a web-based system. The Commercial-Off-the-Shelf system was based on components of Aris Global's Total Safety Suite TSS software package ARISg 6.4s configured to meet global Abbott Laboratories needs.
• Absent for the first three and half years of the project, authored and gathered approval of the Validation / Test Plan document for the entire AEGIS Upgrade 8.0.0 project using the GAMP methodology which quantified and allowed the delivery of the Validation portion of the Computer System Validation engagement. This defined and facilitated the completion of the project by defining the successful completion of the engagement.
• Consulted on the creation of the Validation Strategy
• Created the test protocols/cases for the validation efforts
• Conducted the review and final approval of the Validation documents
• Created the entire suite of validation / test artifacts for System Integration Testing i.e., MS Project Plan, Validation Plan, test scripts, traceability matrix
• Validation consultant on the testing efforts
• Managed the execution of the System Integration Testing of ARISg 6.4.2 integrating with agXchange IRT 6.4.2, agXchange OST 6.4.2, agXchange ESM 6.4, MedDRA Coder Browser MCB, Dictionary and Query Manager DQM, Auto Narrative generator ANG, AEGIS Reporting, PVMonitor-PVtrack, Interactive Reporting Tool IRT, Global Abbott Safety Surveillance GLASS and PVWorkbench PVWB with a team of ten resources
• Oversaw the execution of Smoke Testing of the system new builds and the new development environments with a team of four resources
• Functioned in the pharmaceutical regulated Validation space, GCP, GLP and GMP
• Utilized HP Quality Center 10 to record Validation protocol results and document Validation summaries

Confidential

QA Manager

• Herff Jones upgraded their .NET stand-alone ordering system to web-based e-Commerce system. Moving to a web-based approach streamlined the Sales Representative computing use, increased their ability to conduct e-business and enhanced their ability to interface with corporate and their clients.
• Authored, packaged and delivered all the testing documentation for five project releases
• Authored the Test Strategy and the Test Plan utilizing the Iterative approach
• Created a QA department by establishing the QA standards utilizing best practices, procedures, the RACI Roles and Responsibilities matrix for the testing effort, testing protocol, testing scope, testing deadlines, testing infrastructure, and the testing automation suite utilizing an open source tool, WATIR
• Oversaw the testing phases, managed a team of eight testers and delivered testing on time and on budget
• Defined, created and maintained the testing artifacts and the testing deliverables
• Developed the testing reporting templates and communicated the testing metrics to management
• Defined, maintained and reported on all the testing activities which included defect management, test execution and test artifact generations
• Decreased testing iterations by 30 through vendor code stability, better requirements definition, standardizations and enhanced communications between the development team and QA
• Utilized Adobe Flex Builder and Oracle to implement an e-Commerce system

Confidential

Program QA Manager

• Anthem's call centers utilized several legacy systems to retrieve health care information which resulted in a 45-minute phone call. The FEP WAW Federal Employee Program WellPoint Advocate Workstation project provided a GUI front end layer on top of the legacy systems. This streamlined the exchange of information and decreased a phone call to five ten minutes.
• Oversaw and managed all the testing deliverables for the entire project, all the testing phases including the back end testing, system testing, integration testing, end to end testing, user acceptance testing and production verification
• Created and delivered the testing deliverables for each testing phase, which included the project plan, delivery dates, test plan/strategy, test cases/scripts, requirements/business scenario traceability, testing tools selection and test execution reporting using the Rational Unified Process RUP methodology
• Defined the reporting templates, maintained and communicated the program level testing activities which included defect management, test execution, test artifact generations and testing environment setup to the PMO
• Define RACI Roles and Responsibilities matrix for the FEP testing effort
• Managed the 15 member FEP testing team and their testing efforts across the U.S.
• Coordinated with the Deloitte contingent for code delivery, testing and PMO objectives
• Executed and delivered all testing deliverables on time and on budget
• Utilized Rational to create and implement testing artifacts

Confidential

Engagement Manager

• The AIG GMD engagement was a multi-year project responsible for providing Incident Management and Change Management support. TEKsystems transitioned off-shore support and responsibility from AIG AIA IT, AIG Southeastern Asia to TEKsystems in Bangalore, India.
• Engagement Manager: Represented TEKsystems' interests with the client, interacted directly with the AIG managers on the project status and resolved any concerns, managed for all engagement level tasks, responsible for the engagement financials, created and executed the engagement processes to incorporate the ITIL methodology and contractual obligations and delivered the engagement on time and on budget
• Transition Manager: Architected and executed the Transition Plan for the engagement, Roles and Responsibilities and resource management managed the Transition Phase of the engagement from AIA IT of ten team members to TEKsystems seven team members, identified and resolved gaps in the client's processes, introduced streamline processes, and trained and mentored TEKsystems staff. Created and implemented the Incident Management and the Change Management procedures.
• Connectivity Manager: Defined, designed, configured and implemented the Connectivity Solution for a the connectivity between TEKsystems Bangalore facility's and the AIG Wilmington facility, b configured and implemented the TEKsystems computing facility in Bangalore, by architecting the connectivity solution and leading a nine member team to gain client security access and configure the client's network to allow a secure connection between the client in Wilmington and or Bangalore facility
• Consultant: Consulted on TEKsystems proposals to potential clients. Authored proposals and RFPs, documented the client's current processes, conducted gap analysis, proposed Roles and Responsibilities and enhanced TEKsystems' processes including the ITIL framework and Incident Management/Change Management methodology.
• Engagement utilizing Java, Oracle, MicroFocus COBOL

Optimizing Lead Optimization Project Validation / QA Manager QA Consultant

• The engagement began with the Optimizing Lead Optimization OLO project. The objective was to reduce lead generation time by using a new IT infrastructure to speed the process. The OLO project standardized and automated sample handling, results analysis and management though information technology. The front-end interface was comprised of web applications, various researching source systems and Excel workbooks. The back end was housed in Oracle. The QA effort validates the OLO developed applications while observing GxP GLP and GCP protocols FDA 21 CFR .
• The DIT, GM R IT and DRAS engagements were a six year project responsible for providing Incident Management and Change Management support for 350 production applications GxP and non GxP formerly developed and maintained by Lilly's Discovery IT's Center of Excellence. TEKsystems transitioned support responsibilities from the client to TEKsystems' near-shore support in Montreal, Quebec. This support model utilized near-shore resources to provide Incident Management, Change Management and technical support. The Montreal staff was comprised of 50 technical resources, QA testers, technical writers and developers. The Montreal staff supported TEKsystems' 25 onsite team in Indianapolis.

Validation / QA Manager

Defined, trained, approved and delivered the Validation / QA engagement deliverables Authored, negotiated and sought the approval of all the Validation /QA documentation packages for 20 releases of five OLO systems Managed the validation of three system integration projects, along with authoring and the approval of the associated Validation / QA documentation packages On-boarded TEKsystems Validation / QA testers and the technical writing staff Managed the Validation / QA resources, Validation / QA scope, scheduling projects, resource management, Roles and Responsibilities, Validation / QA process, Validation / QA adhered to the Incident Management/Change Management process and configuration management Mentored the staff on the client's policies and procedures and Validation / QA processes Trained and mentored the Validation / QA testers and technical writers on the client's and TEKsystems' Validation / QA process, procedures and protocols Ensured adherence to the Validation / QA processes for GxP compliance and our contractual obligations Wrote the testing validation documents e.g., Validation / Test Plan, Test Execution Report, Validation / Test Summary Report and IQ/OQ/PQ documentation, performed Annual System Reviews, documented System Retirement/Decommission, created traceability matrixes, managed the execution of manual and automated test scripts and delivered a successful submission of the validation / testing deliverables Utilized RUP methodology and Rational testing tools TestManager, Robot, ClearQuest, RequisitePro, SoDA, ManualTest in the creation, implementation and maintenance of validation / testing artifacts

Solution Delivery Manager

Responsible for the completion of production support work in the Montreal facility as well as complying with the client's established policies and procedures. Incident Manager: Defined and prioritized the scope of work and reviewed the documentation package for completeness and compliance Enhancement Manager: Responsible for Change Management work by defining the scope of work, prioritizing the projects and reviewing the documentation package for completeness and compliance Resource Manager: Managed the entire DIT Montreal staff of 50 technical resources comprised of developers, QA and technical writers conducted performance reviews and resource meetings to staff releases/projects interviewed for technical candidates, assessed technical skill, managed the Roles and Responsibilities, load balance releases/projects, implemented and communicated security policies and regulations and adhered to the Canadian labor laws and regulations Mentored the technical staff and technical leads in Montreal Oversaw the Testing and Validation activities in Montreal Coordinated SDLC operations between Montreal and the client site in Indianapolis Created and maintained processes for the engagement that maintained pharmaceutical compliance, incorporate ITIL and contractual obligations Created and reported status of Montreal facility's activities Enhanced productivity by 20 through improved communication, better defined processes, resource management and team cohesiveness

Transition Manager

Developed, managed and executed the Transition Phase for the engagement from Lilly GM R IT to TEKsystems Principle architect to the current TEKsystems Transitioning process, Incident Management and Change Management process Created processes, policies and procedures for the engagement that incorporated ITIL and contractual obligations while at the same time reflected the clients policies and procedures Transitioned the support and responsibility from the client to the Montreal facility On-boarded TEKsystems staff, defined the Roles and Responsibilities trained and mentored the staff on the Transition process, Steady State process and the policy and procedures of the client and the GM R IT engagement Managed the transition of key components of the engagement Project Manager for the Functional Business Area Transition was completed on time and on budget which allowed TEKsystems to begin fulfilling the support portion of the contract

Validation / QA Consultant TEKsystems and Eli-Lily Pharmaceutical

Updated TEKsystems proposed enhanced processes to include the ITIL framework, Incident Management and Change Management methodology Consulted on TEKsystems proposals to potential clients Performed analysis on Validation / QA projects within Eli-Lilly Pharmaceutical Documented TEKsystems' client processes Proposed Roles and Responsibilities Provided assessments on Validation / QA situations gap analysis report, modifying testing strategy, resourcing recommendations and interviewing prospective testing candidates Provided suggestive course of actions to fulfill their deadlines while maintaining their quality commitments

Audit

Trained and prepared the Montreal staff for a client audit Facilitated Lilly's audit of the Montreal facility Responded to the client's CAPA Designed a plan and utilized the Montreal staff to satisfy the client's CAPA

Connectivity Manager

Designed and configured the Connectivity Solution from the Montreal facility to the Lilly facility in Indianapolis using Citrix servers, remote connectivity to end user environments, point to point connections and implementing connectivity/security protocols Led a team of six technical resources in Montreal and Indianapolis to implement the Connectivity Solution Maintained the Connectivity Solution for a remote offshore/near-shore computing facility in Montreal b secure remote connectivity from offshore/near-shore facility in Montreal to domestic clients in Indianapolis, by architecting the connectivity solution and leading a five person team to gain client security access and configure the client's network to allow a secure connection between the client in Indianapolis and the Montreal facility

• Management responsibilities included conducting meetings, delivering presentations and reports to Lilly senior management
• DRAS milestone included 20,000 hours of technology delivery with zero hours of rework
• Delivered the projects on time and on budget
• Enforced the adherence of the GxP GLP, GMP and GRP quality guidelines and regulations throughout the engagement
• Utilized Java, Oracle, ETL, C, .NET, ColdFusion technology, BI

Confidential

Engagement Manager

• The Specialty Testing group was Liberty Mutual's internal testing resourcing augmentation staff providing Change Management testing support.
• Engagement Manager: Interfaced with the client on their needs, provided engagement status reports, ensured the viability of the engagement and delivered the projects on time and on budget
• Coordinated and mentored 45 development and testing resources within the Liberty Mutual Specialty Testing group
• Created and reported program level status reports and metrics on the TEKsystems progress of testing
• Managed and reported the program level testing efforts for the rebranding of a newly acquired insurance company which the testing effort spanned ten departments Liberty Mutual and newly acquired Ohio Casualty Group
• Utilized Rational testing tools included Robot, TestManager, ClearQuest and RequisitePro

Confidential

QA Engineer

• Liberty Mutual's Regional Agency Management and Planning RAMP application housed the agencies and agents throughout the Liberty Mutual organization, budget and planning for the various agencies and their commissions.
• Created automated test scripts utilizing Rational Robot and executed regression test suites with Rational TestAgent
• Documented use cases, developed manual test scripts, created a comprehensive test plan, project planning, performed gap analysis and conducted Performance Testing utilizing Mercury LoadRunner
• Enhanced and improved the automated test scripts developed in a framework architecture which decreased the development time, increase reusability and ease of automation use
• Utilized Rational testing tools included Robot, TestManager, ClearQuest and RequisitePro

Confidential

Senior QA

• Responsibilities spanned the SDLC to included Project Management, Change Management, test lead, managed the testing group of 30 team members, mentoring, automated/manual testing, created test scripts, documented processes, documented requirements and created test execution reports and technical documentation
• Created and executed End to End Testing, Systems Integration Testing, Functionality Testing, Unit Testing, User Acceptance Testing, defect tracking Netman and Test Director, Recent projects involve testing of the conversion of the RFMS data to the COD system
• Utilized Web front end on an IBM mainframe platform, MVS operating system couple with MQ Series Middleware and utilizes DB2/IMS databases, Student information was format in XML
• Utilized tool sets including TS2, TSO/ISPF, Test Director, Winrunner, Fileaid, DB2/IMS, Netman, CICS and MS Access

Confidential

Senior QA Engineer

• Utilizing FDA 21 CFR Part 11 GLP, GCP and GMP, the DocMan project developed and implemented a computerize system that electronically submitted pharmaceutical compounds for FDA approval. The system was a compilation of Lilly proprietary software programs.
• Created and completed the entire Validation / QA documentation packages Test Plans, Test Summary Reports, Test Execution Reports, completion reports, validation testing documents and testing status reports for five software release under the RUP methodology
• Documented the testing process, coordinated the testing projects and UAT
• Managed five testers for the DocMan testing effort, Change Management, advised the test lead, ensured system compliance with the FDA guidelines, scheduled resources, monitored test process flow, mentored and oversaw new testers and met the testing deadlines
• Ensured staff adhered to the client's policies and procedures and QA standards
• Demonstrated Rational Robot and our automate process to other departments
• Utilized Rational to test the quality and functionality of multiple software releases
• Created testing requirements, requirements traceability matrix, test cases and executed automated test cases utilizing Rational TeamTest 7.5 / 2000 and Rational RequisitePro performed defect tracking using Rational ClearQuest
• Enforced the adherence of the GxP GLP, GMP and GRP quality guidelines and regulations

Confidential

QA Manager Crystal Report Designer Programmer

Micro-Mega Databases was a software company developing a rail management system. Responsibilities span the entire SDLC, project management and QA Manager.

QA Manager

Documented testing processes, SDLC procedures, technical changes, technical specifications, technical requirements and instructions Developed and managed the testing team of seven resources Defined and implemented the testing schedule, testing scope of work and delivered the projects on time and on budget Utilized Rational products to manage the testing artifacts, RUP testing methodology and Rational ClearQuest for defect tracking Tested the e-Commerce division products

Crystal Report Designer: Developed the report module of the rail management system in Seagate's Crystal Reports

Programmer: Utilized Visual Basic 6.0 to integrate the reporting module with the rail management system

Confidential

Senior QA Engineer UAT

• Ocwen developed a mortgage software system, REAL-e.
• Participated in various aspects of the SDLC. Created and implemented test procedures, defined design scopes, created functional requirements, worked on the End to End project, Processes Testing, Unit Testing, conducted Joint Application Design JAD sessions and created a System Ready QA Check List to expedite testing iterations
• Created technical requirements, specifications, procedures and documents
• Identified and authored User Acceptance Tests for different aspects of REAL-e

Confidential

Senior QA Engineer Business Analyst

• The Distributed Technology Refresh Initiative DTRI Project was a subset of the Year 2000 Project of converted 1,800 PC based applications, residing on a variety of platforms and migrated them to a standardized Windows NT Workstation 4.0 platform.
• QA Engineer: Created test cases, wrote manual/automated test scripts and generated Wachovia installation scripts in Rational TestManager and Robot, with the DTRI technical group
• Business Analyst: Liaison between the DTRI technical group and the Business Units

Documented the technical specifications and requirements including test objects, UAT objects, custom installation instructions, application dependencies and application analysis Conducted JAD sessions and assisted in the creation of the DTRI processes Performed Hardware Sanitation, created automated installation scripts for the hardware device drivers Attended SQA Suite Product Training class

ROLES and RESPONSIBILITIES

Program Validation Manager, Program QA Manager, Validation / QA Consultant, Project Manager, Engagement Manager, Change Manager, Incident Manager, Solution Delivery Manager, Transition Manager and Resource Manager

SOFTWARE

MS Excel, MS Word, MS PowerPoint, MS Sharepoint, MS Project, HP Quality Center, IBM Rational ClearQuest, RequisitePro, TestManager, Functional Tester, TeamTest Suite and Robot, Mercury Test Director and Winrunner, Netman, TS2, TSO/ISPF, Fileaid, DB2/IMS, CICS and MS Access

ENVIRONMENT / TECHNOLOGY

e-Commerce, Web-Based Applications, Oracle, ETL, Data Warehouse, Data Mart, SAP SAP ERP, AII, PI and OER, ARISg ARISg AEGIS and ARIS Global's Total Safety Suite TSS, Adobe Flex/Flash Builder, Eclipse, Juno, JBoss 5.1, Rally, Citrix, DB2/IMS databases, Java, C, Visual Basic, .NET, ColdFusion technology, MicroFocus COBOL, Business Intelligence BI, Crystal Report and REAL-e

TESTING METHODOLOGY

GAMP, Agile, RUP, Iterative and Waterfall

REGULATORY

GMP, GLP, GCP, GRP, GxP and CAPA

CLEARANCE

5-C Security Clearance

MEMBERSHIPS

Indianapolis Workshop on Software Testing Organizer and Facilitator

Indianapolis Quality Assurance Association, Inc.