Project Manager Management

Dionna J. Small, MBA

**** ******** *****, *******, ** 27610 - 919-***-**** (H) / (919) 614-

**** (C)

http://www.linkedin.com/in/dionnajonessmall

HIGHLIGHTS

Computer systems validation, testing and quality lead with over 10 years of

experience in the Pharmaceutical and Clinical Research Industry.

Regulatory SME in SOX and 21 CFR Part 11 compliance. A strategic thinker

and pragmatic problem solver with keen insight and understanding of

regulatory requirements who desires to maximize business efficiencies

through the implementation of high quality, efficient and compliant IT

systems. An effective leader leveraging small and large validation

efforts, test teams, projects and project teams with experience managing

and training FTE's and a proven record of success in effectively leading

validation and testing efforts.

COMPUTER SKILLS

Software Applications/Tools: Labware LIMS, TrackWise, Qumas DocCompliance,

PeopleSoft Financials 8.4, 8 .9, and 9.0, SAP ECC6.0, HP Openview, TOAD, HP

Quality Center 9.0 and 9.2, BMC Service Desk, MantisBT, HP Project and

Portfolio Management (PPM), Microsoft Office: (Word, Project, Power Point,

Access, Outlook, Publisher and Excel), Mercury Kintana.

PROFESSIONAL EXPERIENCE

Purdue Pharmaceuticals, Wilson, NC

Sr. Quality Specialist III, Information Systems Quality Assurance (06/13 -

Present)

. Responsible for all aspects of regulatory compliance for computerized

systems at the Wilson, Totowa and Rhodes Tech facilities.

. Assure compliance with federal regulations and company standards for

all computerized systems and equipment.

Sr. I/T Validation Analyst (03/11 - 06/13)

. Responsible for all aspects of IT Systems Validation and IT

Compliance, including guidance on validation and qualification of all

computerized systems and IT infrastructure at the Wilson

manufacturing facility.

. Develop and manage IT Validation/Qualification Documentation

following Polaris SDLC guidelines in a cGMP and FDA regulated

environment.

. Manage and oversee validation efforts for all projects from the

inception phase thru the release phase in accordance with Polaris

SDLC guidelines and project schedules.

. Manage the development, review, and change control of computer system

requirements and design documentation to ensure that critical systems

are in compliance with FDA regulations as well as industry standards.

. Manage change control on existing validated systems/servers to ensure

that all changes are documented and implemented in accordance with

standard operating procedures.

. Manage and develop IT manufacturing and lab processes for validated IT

manufacturing and lab systems.

. Manage QA and QC efforts and FDA compliance of TrackWise, Labware LIMS

and other Quality and Manufacturing Systems.

. Work with business leads and users to gather and write user

requirements.

. Author validation documentation including, Project Initiation

Documentation, User and Functional Requirements Specifications, Design

Specifications, OP/QP Test Scripts, Validation Plans, Operational and

Performance Qualifications (OQ/PQ), Project Delivery Reports, Project

Closure Reports, Traceability Reports, and SOP's.

. Oversee and provide resolution for corrective & preventive action

(CAPA) items to ensure that problems are resolved.

. Ensure that Systems Validation and Testing deliverables are completed

on time and in adherence with SOP's.

. Manage the index and storage of all FDA compliant documentation for

Wilson information systems.

. Manage and create workflows in the document management system

(DocCompliance) for the Wilson regulated repository.

. Provide a leadership role in the participation and guidance of

internal ISQA and FDA audits and external vendor audits.

Quintiles Transnational (CRO), Morrisville, NC (07/09/2007-01/31/2011)

IT Systems Validation and Testing Lead (06/08 - 01/11)

. Primary point of contact for systems validation and testing

activities.

. Worked closely with Project Managers to define project scope,

schedule, and requirements.

. Managed systems validation test team and offshore resources.

. Developed validation plans, testing strategies, test plans, and

validation reports for regulated systems following SDLC Guidelines to

meet QA Standards.

. Provided feedback and status reports to Directors and Stakeholders.

. Assisted with user/business requirements and fit gap analysis and

provided input to help develop high quality and detailed user and

functional requirements and ensure traceability.

. Ensured that 21 CFR Part 11 requirements were covered during testing.

. Ensured that Systems Validation and Testing deliverables were

completed on time and in adherence with SOP's.

. Ensured that the project schedule was adhered to and the work was

completed according to the project schedule.

. Planed, organized, and monitored the execution of work assignments for

the Test Team.

. Ensured creation of test data to support test case execution and

support creation and maintenance of libraries of reusable test data

sets.

. Coordinated the design, writing, and execution of tests to prove

systems functionality and to ensure business and user requirements

were met so that systems would operate as expected in the production

environment.

. Performed internal peer reviews of test cases produced by the Systems

Validation Testing team prior to and following execution as required

to ensure issues/errors with the test scripts were identified and

resolved.

. Created Validation Packages that were sent to the System Compliance

Office (SCO) for review prior to production release.

. Provided a leadership role in the participation and guidance of

internal and customer audits.

. Leveraged automated testing tools for test planning and management,

test case authoring, test case execution, issue/defect tracking, and

traceability.

. Reviewed the design specification and other technical documents to a

high standard to enable the discussion of the specification with the

user community.

. Conducted UAT tester training for over 100 users as the HP Quality

Center System Administrator.

Global I/T Change Control & Production Release Coordinator (07/07 - 05/08)

. Provided a leadership role to the PeopleSoft Financials support team

for project implementations and coordination of all system changes in

the production system environment.

. Coordinated database refreshes for test and support system

environments and provided communication to database users.

. Managed and tracked change tickets and work orders related to system

changes.

. Worked with Business Analysts, Development team and DBA's to ensure

that change requests were developed and requirement documents were

completed and tested prior to migration to Production.

. Worked with production support team as HP OpenView (HPOV) system

administrator to ensure that support requests were assigned and

addressed in a timely manner.

. Served as Oracle Customer Connection System Administer.

. Reviewed and assigned new service/support requests (SR) to support

analysts and reviewed SR queue with support analysts to ensure that

production issues were being resolved in a timely manor.

. Conducted Management Review meetings in regards to open support

requests, production releases and outstanding issues.

. Conducted quarterly SOX testing activities.

. Provided continuous process improvements to the change management

process.

. Provided change management training for Corporate Solutions, Global

Solutions Product Support and Super Users.

. Evaluated test documentation and made recommendations for improvement.

. Reviewed and approved user test plans.

. Managed and tracked test and migration documentation to ensure SOX

compliance.

Bausch & Lomb, Rochester, NY (1999-2007)

PeopleSoft Global Process Owner (05/04 - 06/07)

. Provided a leadership/management role to the PeopleSoft global project

team and provided coordination, oversight and completion of projects

to drive successful PeopleSoft implementations within all B&L global

regions.

. Managed PeopleSoft Supply Chain Management, Order Management & Pricing

Production Support teams.

. Provided support to Order Management, Customer Master, Products,

Pricing, and Inventory modules within the Global ERP.

. Interacted with global business managers and regional owners to define

and document user and functional requirements and to ensure that

requirements were met.

. Developed process flows, user and functional requirements and design

documents specific to new enhancements, interfaces, reports, and

conversions.

. Ensured that key business operations were addressed by the delivered

PeopleSoft system and significant gaps were acknowledged through

customization or work around processes.

. Provided status updates and reports to senior management regarding

project status.

. Worked with IT development team to implement system enhancements,

designs, and change requests.

. Conducted SOX testing and process review meetings to ensure that

proper documentation was in place for SOX compliance.

. Supported design and upgrade functionality decisions, configurations,

coordination & testing.

. Supported conversions from legacy systems to ERP system.

. Supported business process change strategies.

. Provided subject matter expertise and training.

. Managed and authored SOP's.

PeopleSoft Financials Testing Lead (05/03-05/04)

. Provided subject matter expertise and test coordination for PeopleSoft

A/R and Billing modules.

. Developed test plans and detailed test scripts for Order Management,

Inventory, A/R, and Billing modules.

. Performed testing related to PeopleSoft application bundles,

PeopleTools Upgrades, Disaster Recovery, Site Integration Tests, User

Acceptance Tests, and Regression Testing.

. Provided a leadership role to drive process improvements/reengineering

efforts within the Customer Process Team subsequent to the multiple

PeopleSoft implementations within the Americas region.

Process Professional/Project Manager (04/00-05/03)

. Identified and implemented continuous process improvements within the

North Americas Shared Service Center credit and collections

department.

. Worked closely with internal and external customers, sales reps, and

vendors to ensure that customer needs and Service Level Agreement

requirements were met.

. Led various projects within the Shared Service Center from the

inception phase through the support phase to continuously improve

processes.

EDUCATION

Medaille College, Buffalo, NY

MBA, Business Management, February 2005

University of North Carolina at Greensboro, Greensboro, NC

Bachelor of Science Degree, Management & Marketing, May 1999

ADDITIONAL TRAINING & CONFERENCES

Compliance Online, Computer System Validation - Reduce Costs and Avoid

483's, March 2014

. Introduction to the FDA

. 21 CFR Part 11

. The 5 Keys to COTS Computer System Validation

. 10 Step Process for COTS Risk-Based Computer System Validation

. How to Write Good Requirements and Specifications

. How to Conduct a Hazard Analysis/Risk Assessment

. Software Testing

. System Change Control

. Cost Reduction without Increasing Regulatory or Business Risk

CSQA Exam Prep Course, March 2013

IVT 13th Annual Computer and Software Validation, April 2012

. How to Develop Robust Software & System Requirements to Achieve

Sustainable Maintenance of Requirements

. How to Overcome the Most Common Computer and Software Validation

Problems

. How to Create Test Plans and Test Scripts that Maintain Validation

Protocols

. A Deep Dive into CFR Part 11 - Maintaining Compliance for Electronic

Records & Signatures

. Global Regulation Overview of 21 CFR Part 11 and Annex 11 for Computer

Systems

. How to Manage Test Incidents During Validation

. How to Test and Validate Software throughout the Development Lifecycle

References Available Upon Request

Contact this candidate