SUMMARY:

• Confidential has demonstrated ability with 12+ total years consulting experience in Federally regulated environments at Fortune 500 Pharmaceutical. Manufacturing, Telecommunications companies, as well as state government, progressing from Business Analyst to Project Manager and specializing in IT project delivery using PMBOK and Agile best practices. Deanne has proven expertise in communicating at the highest level within fortune 500 companies as a seasoned Project Manager.
• As a manager and leader of people or projects, Deanne is:
• Focused with firm discipline on her team's production of accurate, high quality work
• Analytical, creative, methodical, and at times innovative in solving technical problems for her team, department, or company
• Intent on providing her team with a validated, sanctioned template by which to measure all work; she is constantly and calmly revising that book to ensure it's appropriate for 'today's challenges'
• Leads by example and with team - oriented activities
• After delegating- her follow-up is close, thorough, and uses immediate feedback that is kept respectful of the individual
• Disciplined, relaxed and thorough; she protects the company from undue risk by thinking through the implications of decisions and applying solutions that have some proof to back them up and can be systematically implemented by herself and her team

TECHNICAL SKILLS:

SKILLS: Experience Last Used Project Management (PMBOK v.3.0 - 5.0) Advanced 8 years Current Agile Scrum Methodology (Certified Scrum Master- ScrumAlliance.org) Advanced 8 years Current Scope Management Advanced 8 years Current Schedule Planning, Management, and Reporting Advanced 8 years Current Budget Estimation, Maintenance, and Reporting Advanced 8 years Current Resource Planning, Management, and Reporting Advanced 8 years Current Vendor Procurement, Management, and Reporting Advanced 8 years Current Change Management (ITIL) Expert 10 years Current Release Management (ITIL) Advanced 8 years Current COTS Implementation Advanced 8 years Current Team Management, Team Building, Leadership Advanced 8 years Current Business Intelligence, Dashboard Development Advanced 3 years Current Data Warehouse Development Advanced 2 years 2015 Business Process Engineering Advanced 10 years Current Requirements Analysis and development Expert 10 years Current Use Case Definition Expert 10 years Current Reverse Engineering of Legacy systems to requirements and design of new systems Advanced 10 years Current 21-CFR-11 Computer Systems Validation Expert 9 years 2015 System Development Life Cycle Methodology (Unified Process) Expert 12 years Current Microsoft Office Tools (Word, Excel, Visio, Power Point, MS Project Advanced 10 years Current Testing (Test Planning, Test Scripting, Test Summary Performance) (Applications: MSWord, HP Quality Center) Advanced 8 years Current

PROFESSIONAL EXPERIENCE:

Confidential, Chicago, IL

IT Project Manager

Responsibilities:

• Responsible for Enterprise wide Implementation Schedule
• Responsible for maintaining project change management processes
• Responsible for maintaining expenses and capital expenditures within approved budget
• Responsible for presenting monthly metrics to project sponsors.
• Responsible for Risk Management and troubleshooting issues to resolution.
• Responsible for coordinating vendor and workshops,
• Responsible for coordinating multiple levels of product testing to ensure process meets design and configuration.
• Responsible for driving Teams to gather requirements and reverse engineer current processes to facilitate the redesign of process into the new tool’s design.
• Responsible for maintaining Team calendar, Team meetings and Team SharePoint site.

Confidential, Indianapolis, IN

Senior IT PMO Program Project Manager

Responsibilities:

• Responsible for maintaining solution Scope and ensuring Enterprise wide Release Schedule
• Responsible for maintaining change management processes
• Responsible for gathering and presenting time and cost estimates to project sponsors to gain funding approval
• Responsible for maintaining expenses and capital expenditures within approved budget
• Responsible for presenting monthly metrics to project sponsors.
• Responsible for Risk Management and troubleshooting issues to resolution.
• Responsible for overseeing the coordination of facilities and teams (both on site, co-located, and international) for design and implementation of network infrastructure
• Responsible for ensuring the approval, purchase, delivery and deployment of network hardware. This included servers, virtual servers, operating system software, fiber optic and copper cabling, f5 devices, and Cisco firewalls

Confidential

Program Project Manager

Responsibilities:

• Leveraged use of an IT Only minor change control board for enabling change in all non-production environment by increasing CCB meetings to 2x weekly and reclassified “minor change” definitions to include common virtualization tasks not previously defined.
• Coordinated application and engineering teams to create task check lists for virtualizations of different types of environments (linux, unix, windows) and scheduled virtualizations with multiple teams within the CCB process using short agile scrums.
• Leveraged relationships with application teams, engineering teams, and C-Level executives to negotiate and schedule virtualizations of production environments where effect on manufacturing was limited to control risk (no shut down or only minor outages(8hrs)) using the CCB processes for Major Change.

Confidential, Raleigh, NC

DHHS Project Manager

Responsibilities:

• To define the Product Backlog and Product roadmap for the nominated product(s). Set a clear vision and Release Plan for the product(s)
• Develop a deep understanding of the customer’s needs, HIPPA and Privacy Information (PI)
• Use of both traditional SDLC and Agile Methodology to re-prioritise the Product Backlog based on customer feedback and business priority, manage stakeholders, and developed product.
• Provide regular reporting including product spend, scope, schedule and planning.
• Significant practical experience in: information technology staff supervision, project management related to information systems’ efforts, development of business/functional requirements (Product Backlog), RFI’s, RFP’s, Federal level reporting documentation and systems analysis.
• Experience in providing application support, development, configuration and administration of document management systems such as Documentum or IBM FileNet.
• Experience with the following technologies: Documentum 6.x or IBM FileNet, Windows OS, PDFAqua, Oracle, DCM.
• Understanding of the core functionality and the associated business processes of a Social Services organization

Confidential, Atlanta, GA

Senior Enterprise IT PMO Project Manager

Responsibilities:

• Responsible for maintaining solution Scope and ensuring Enterprise wide Release Schedule
• Responsible for maintaining change management processes
• Responsible for gathering and presenting time and cost estimates to project sponsors to gain funding approval
• Responsible for maintaining expenses and capital expenditures within approved budget
• Responsible for presenting monthly metrics to project sponsors.
• Responsible for facilitating application design review sessions for functional business requirements, system requirements, network requirements, and system interface requirements for end to end design solution.
• Responsible for overseeing the coordination of facilities and teams (both on site, co located, and international) for individual application unit testing, end to end system functional and interface testing, and user acceptance testing
• Responsible for ensuring the approval, purchase, delivery and deployment of network hardware. This included servers, virtual servers, operating system software, fiber optic and copper cabling, IPAG switches and replacement of 4x10 GE network switching cards to 16x10 GE cards
• Responsible for reviewing all levels of project and system documentation within the expected deliverables of a System Development Life Cycle and details therein to meet FCC System Validation standards.

Confidential, MtVernon, IN

Projects Indiana Technical Operations

Responsibilities:

• As a Project Manager, I was responsible for planning, managing team members, executing, monitoring, and controlling project processes using Agile scrum principles that re-engineered formal business processes for Pharmaceutical Manufacturing and Master Batch Records systems in an FDA Regulated environment. This project also includes configuration and deployment of Emerson Syncade software through the System Development Life Cycle FDA compliant and validated to 21 CFR 11, of employees, implementation of new policies and procedures using agile methods.

Confidential, Indianapolis, IN

Test Manager- Project Management

Responsibilities:

• With technical communication skills and experience with Quality assurance, quality control and continuous improvement processes, I demonstrated the ability to function effectively as a Test Manager-Project Manager by planning, managing team members, executing, monitoring, and controlling formal system testing and defect management for release one of LillyMedical.com web application using agile scrum methodology.

Confidential, Indianapolis, IN

Requirements Manager

Responsibilities:

• Analyze the impact of system change activities for Federally regulated computer systems across the various IT functional business areas in Lilly, Global Medical and Regulatory IT. Produce project requirements for product scope, activity lists, and schedules.
• Analyze validation efforts to align and implement best practices and standards, communicate status, manage expectations, resolve issues, and insure continuous improvement and top quality service.
• Identify corrective and preventative actions to bring the systems back to a validated state and ensure its continued compliance.
• Coordinate the production of deliverables in accordance with company standards to ensure robust levels of GxP compliance with 21 CFR 11.
• Worked closely with Technical/Support Analysts, Business Analysts and customers to understand, define and ensure customer expectations are met, keeping customer informed on the status of projects
• Managed the planning and execution of retiring legacy systems, instruments, and applications acting as primary point of contact between customer and the project staff,. This included software systems, tools, hardware, documentation and archiving of data without loss of data accuracy, data integrity, and fully retrievable in human readable formats.
• Coordinated the development and validation of utilities or tools to be used during the retirement process to convert and/or store data in a retrievable format. Used agile scrum methodology.
• Responsible for the accuracy of plans, reports and other documentation necessary to retire a system and/or archive data.
• Responsible for estimating and projecting the potential workload for future work
• Responsible for planning and projecting workload with specific recommendations to accommodate needs.

Confidential, Indianapolis, IN

Project Manager

Responsibilities:

• I assessed the compliance of regulated computer systems with their corporate standards and Federal standards contained within 21CFR Section 11. Recommend corrective and preventative actions. Monitor and control action plans, manage team members, execute tasks, and ensure quality standards are used to complete tasks to regain or maintain compliance.

Confidential, Indianapolis, IN

Business Analyst

Responsibilities:

• Produced validation deliverables in accordance with company standards to ensure robust levels of GxP compliance with 21 CFR 11. Analyzed validation efforts to align and implement best practices and standards, communicate status, manage expectations, resolve issues, and insure top quality service. Supported the various IT functional areas in the deployment, execution, change control, and ongoing maintenance of validation deliverables and activities for systems that supported Admin Lims, Vendor Privacy, Adverse Events Reporting, Clinical Trials, and Regulatory Submissions
• Identified boundaries and scope of validation responsibility for new development, enhancements, retirements, and maintenance projects as assigned.
• Coordinated with management across cross-functional teams to ensure compliance of validation documentation with corporate policies and procedures. Communicated validation and compliance status to quality representatives and system support teams.
• Identified corrective and preventative actions to bring the system back to a validated state and ensure its continued compliance.
• Participated in the development of system test plans and test cases and conducted quality assurance analysis of test performance to identify testing and quality gaps
• Assisted in improving Test Strategy and Test Planning processes while collaborating with other team members resulting in an improvement of testing processes and shortening testing durations.
• Reviewed test cases of other team members for quality assurance and compliance with corporate policies and procedures. Analyzed computer systems to identify gaps in CFR 21 section 11 compliance.
• Analyzed test cases in comparison to documented requirements and design to ensure proper traceability of requirements to test.
• Conducted system tests using Rational Tools- ClearQuest, RequisitePro, Rational Rose, ClearCase, Test Manager.

Confidential, Indianapolis, IN

Business Analyst

Responsibilities:

• I elicited, analyzed and produced validation deliverables that appropriately corresponded to business and system requirements, developed use cases, business scenarios, supplemental software specifications, and supporting UML models for an ISO 9000 series CAPA system that encompassed global manufacturing quality business processes for change management, deviation management, incident management, and FDA commitments.
• Used Quality Assurance methodologies to analyze business processes in preparation for computer systems development and produced the appropriate validation deliverables.
• Helped to develop testing strategy, designed test scripts, and produced appropriate validation deliverables for system under construction. The system was designed using Rational Unified Process Software and compliant with 21 CFR 11 Standards.

Confidential, Long Beach, CA

Business Analysist

Responsibilities:

• Confidential, Inc., I elicited, analyzed and developed business and system requirements, developed use cases, business scenarios, supplemental software specifications, and supporting UML models for company’s flagship eBusiness product. In addition, I was responsible for managing the GUI design and programming of application help systems and all end user documentation..
• I was responsible for managing all aspects of the deployment for the Rational Software product company-wide. Additional projects managed during tenure included set up of email marketing strategies using html, creation and editing of power point presentations for investor relations and sales, electronic formatting, editing and file conversion to pdf formats of numerous manufacturer product manuals in preparation for uploading to eSupport websites.