**** ********** ***** *****

Raleigh, NC *****

ad0acm@r.postjobfree.com

ad0acm@r.postjobfree.com

317-***-****

Robert Armstrong

Over 30 years’ experience in Project Management, Systems Development, Validation Management, Test Management and Integration Management as well as experience with FDA 21 CFR parts 11/210/211/820 GMP/non-GMP documentation, FDA Consent Decree, Vendor Audits(GMP,GxP,GCP) Highly skilled in Project Management, Agile, CRM, Test Methodologies,GAMP-5, GMP Validation Methodologies, SOP Development, ServiceNow, Project Management and Development Methodologies, Budgeting, Hiring, Training, Managing and Motivation of multiple project teams along with Setting Goals and Evaluating Performance.

I am a seasoned leader with excellent communication skills and a strong technical background that focuses on results, teamwork, and continuous improvement. I have a reputation for getting the job done.

HARDWARE &

SOFTWARE: IBM, SUN, HP, DB2, SQL Server, Oracle 6.x-8i, SQL, RUP, Rational Suite Testing Tools, Cobol/ CICS, I-CASE, MS Office, NT, MS Project, MS Access, CRM, Siebel, Remedy, Clarify, Selectica, ERP, SAP S/4, Baan, HP ALM,

JD Edwards, Middleware, Ariba, Commerce One, Web methods, Blue Martini, Tibco, Vitria, JAVA, JSP, Oracle Forms/Reports, C++, VB, Cobol II, CICS, PL1, SAS, Easytrieve, XML, JDK, API, PowerBuilder, Web Sphere, BPM, BizFlow, Six Sigma, EDI, E-Portal, Platinum Project Management, Navigator System Series, Agile Technology Development Process, Lilly LSEF, Critical Chain Project Management, Autonomy e-Discovery, IDOL, Email Xtender, ECA, Investigator, Introspect, SOP documentation, FDA related CSV Auditing, GCP/GXP compliance GMP/non-GMP Validation, GAMP-5, SharePoint, Dynatrace, ServiceNow, Microsoft Teams, Azure DevOps, POMS MES, QDoCCS

EXPERIENCE

12/19 – Current VERTEX Pharmaceuticals Inc, Boston, MA

Validation Lead (TCS)

●Validation Lead for Nuvolo Installation, Testing and Validation Deliverables converting from manual to automated system.

●Validation Lead for POMS MES Installation, Testing and Validation Deliverables converting from manual to automated system.

●Responsible for coordination and management of offshore TCS staff.

●Responsible for Validation Documentation along with Business Management and Quality Management.

7/18 – 12/19 Humana, Louisville, KY

Project Manager (TCS)

●Project Manager for Humana Application Repository – EAPM/iServer.

●Responsible for offshore TCS staff.

●Created processes to improve EAPM Asset Archiving, saving Humana over $3 Million in Server costs.

●Project Manager for Intake Monitor Process for Dynatrace, SiteScope, Appmon and NAM Application Monitors.

●Responsible for implementation of Azure DevOps process for Intake Monitors.

●Project Manager for implementation of ServiceNow design and implementation for Humana Intake Monitor process as well as reconciliation of Clarity accounting issues.

●Regular communication with Senior Management at Humana.

8/16 – 4/18 Stryker, Portage, MI

Validation Lead (TCS)

●Validation Lead for over 15 Non-ERP Systems.

●Validation Lead for Major Data Migration Project.

●Validation Lead for Major SAP S/4 installation replacing over 48 ERP systems.

●Validation Lead for HP ALM UAT Testing.

●Responsible for managing other Validation Leads on SAP project.

●Responsible for Production Change Control for Implementation of SAP project.

3/15 – 5/16 AbbVie, North Chicago, IL

Validation Lead (TCS)

●Short Term assignment, responsible for assessment of Validation Strategies and deliverables for On-Shore/Off-Shore activities for a large project for AbbVie.

8/15 – 2/16 Zimmer Biomet, Warsaw, IN

Validation Analyst (TCS)

●Responsible for Gap Assessment of current Biomet System Validations.

●Identified GAMP Classification for Legacy Validations.

●Identified missing/inadequate validation documentation for accuracy and completeness to follow current corporate CSV Policies/Procedures.

●Reviewed validation compliance with FDA GAMP-5, 21CFRPart11, 21CFRPart820, ISO13485.

●Identified metrics for validation remediation for applications in defined scope.

4/15 – 6/15 Mallinckrodt Pharmaceuticals, St. Louis, MO

Contract Validation Consultant (Safis Solutions)

●Responsible for assessing current Validation and IT Quality systems.

●Performed Risk Assessment on current Validation processes.

●Proposed Validation strategies improvement recommendations.

●Composed Validation documentation as needed.

●Created Policies and Procedures to assure FDA/GAMP-5 compliance.

●Reviewed validation documentation for accuracy and completeness.

8/13 – 2/14 Covance, Indianapolis, IN

Contract Software Validation Engineer (TEK Systems)

●Responsible for validating a broad range of business functionality within the contract research industry including protocol and trial management, sample storage and shipment, and kit resupply.

●Provided LIMS Validation services to the world leader in the CRO market.

●Tested Lab-Ware interfaces with a variety of external systems, including instruments, Data Innovations instrument middle-ware, kit production, billing, TIBCO middle-ware, and data translation services.

●Executed tests and performed defect analysis/resolution for items found both by the script, and peripheral issues noticed during test execution.

●Completed assignments on time.

12/12 – 3/13 McNeil-J&J, Fort Washington, PA

Contract CSV Test Coordinator (Valiant)

●Responsible for Test Script Creation, Dry-Run Testing and Formal System Testing as well as Test Defect Resolution for Investigation, CAPA and LIMS systems under Consent Decree by the FDA.

●Accountable for project planning, weekly status reporting to senior level of management.

●Created Processes for CSV System Testing and Test Defect Resolution.

●Assisted with Audit of INV/CAPA CSV Processes, SOPs and Validation documentation.

●Completed Assignment by the original commitment date.

8/11 – 12/11 Eli Lilly, Indianapolis, IN

Contract Project Manager (BCforward)

●Responsible for managing and implementing 3 large Global SAP CRM projects for the Sales/Marketing Division, utilizing both on-site and off-shore vendors.

●Accountable for project planning, issue/risk management, weekly status reporting to senior level of management.

●Utilized Critical-Chain (Pro*Chain) in conjunction with Lilly’s LSEF to plan, manage and drive projects to completion.

●Completed and implemented all 3 projects on-time by the original commitment date.

12/09 – 5/11 Armstrong Technologies, Inc., Indianapolis, IN

Management Consultant (Corp-Corp)

●Coordinated and managed implementation of corporate vendor solutions.

●Completed Audit of current systems documentation/SOPs

●Responsible for vendor selection/negotiation, project planning, status for small/medium businesses, reporting to various levels of management.

●Responsible for both timeline and implementation planning.

3/08 – 12/09 Eli Lilly, Indianapolis, IN

Contract Project Manager (DSS Consulting)

●Responsible for managing and implementing a $30 million SAP e-Discovery solution project for the Legal Department, delivering a substantial first-year return on investment.

●Accountable for vendor selection/negotiation, project planning, personnel management, issue/risk management, status reporting to various levels of management.

●Utilized both Agile and Critical Chain Methods in conjunction with Lilly’s LSEF to manage and drive project completion.

●Responsible for Instructional design/training plan, including vendor selection, timeline and budget plan as well as implementation planning.

1/07 – 3/08 Cintas, Columbus, OH

Project Manager (Pillar Technologies)

●Responsible for coordinating and managing remote team for the development and replacement of the corporate invoice system for Cintas Corporation in Cincinnati.

●Accountable for project planning and budget using an agile-type process developed by Pillar Technology.

●Responsible for creation of Cintas CBT, OBJ Web based training with outside vendor.

5/03 – 8/06 Eli Lilly and Co., Indianapolis, IN

Contract Validation Manager (DSS Consulting)

●Plan, organize, monitor, control and develop documentation and test plans/cases/scripts for the GMP and non-GMP validation of NetTrax, WinNonlin, ADME/LIMS, NONMEM and systems/equipment that comprise drug development efforts.

●Performed Audit of current CSV documentation, created checklist to meet FDA approval.

●Develop and implement Instructional Training Plan for testing portion of validation effort.

●Collect, analyze, define and develop documents for the following: Validation Plans, Business Continuity Plans, Disaster Recovery Plans, Code Review Procedures, Contact and Resource Lists, Change Control Plans, Installation Qualifications (IQs), Operation Qualifications (OQs), Master Document Plans, System Requirements, Design Requirements, Roles and Responsibilities Definitions, Security Administration, Test Plans and Test Scripts. Performed Dry-Run and System Testing.

●Research and set organizational boundaries and define responsibilities for project elements for all of the project’s global and local stakeholders.

●Determine risk factors, including technology risks, product complexity risk, and validation acceptance risks based on internal Computer Systems Quality (CSQ) requirements.

●Determine the schedule for the various project functions, activities, and day-to-day tasks along with key project milestones in calendar time or in increments relative to milestones.

7/01 – 5/03 Conseco Insurance Group, Carmel, IN

Consultant Project Manager (DSS Consulting)

●Project Manager responsible for deployment and testing of BPM Software to over 20 Business Units. Coordinated 3 Project Managers.

●Created, developed and implemented unique BPM test methodology for unit, integration, system, and model office testing for testing BizFlow projects.

●Responsible for Test Planning and Test Metrics for the BizFlow Program Developed Quality Metrics for testing and project status.

●Created project deliverables such as Project Charters, MS Project plans, Requirements Designs, Instructional Design/Testing Plans for BizFlow projects

●Responsible for planning and creation of strategic and tactical project communication for BizFlow program with senior management.

●Completed 5 projects in less than 12 months.

3/01 – 6/01 Eli Lilly & Co., Indianapolis, IN

Consultant Test Manager (Volt)

●Responsible for the testing and implementation of a Web based submission application to submit clinical trial data to the FDA.

●Part of team of 6 test consultants to Validate and Verify the accuracy of the Metadata.

●Created Test Plans, Test Cases, Test Scripts and Test Data, then executed and logged results utilizing the Rational Test suite along with SAS.

●Completed the 3-month project on schedule and within budget constraints.

3/00-- 3/01 Viador, Inc., San Francisco, CA

Strategic Account Project Manager

●Technical Project Manager of Strategic Account Technical Account Managers for over 50 Strategic Accounts related to Enterprise-Internet E-Portal package installation, customization and issue resolution.

●Managed installation and User Acceptance Testing for several high profile customers, such as Xerox, HP, GM and Tenet Healthcare. Managed multiple accounts relationships, based on customer requirements and needs.

●Hired, managed and mentored technical account management team in a virtual mode, while developing new procedures and processes for the Test Teams and customer support organization.

●Developed Instructional Test Design Plan with outside Vendors to train customers on Viador intranet product.

●Responsible for identifying over $4 million in up-sale/cross-sale opportunities as well as managing 5 major strategic accounts successfully to use as industry references.

TRAINING &

CERTIFICATION:

●GAMP-5 Certified training

●PMP- PMI Certified Project Manager training

●E&Y NSS Project Management Certified

●McDonnell Douglas-Project Management Certified

●CDP-Certified Data Professional

●Azure DevOps

●Agile Development

●POMS MES

EDUCATION: Indiana Purdue University at Indianapolis, Business

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