Project Manager Quality Systems

Nancy Reginelli

513-***-**** ***********@*****.***

Aiken, SC

Customer-focused project manager with exceptional business partnering skills. Develops and prioritizes requirements based on customer needs. Flexible decision-maker with excellent organization, communication, critical thinking, and issue management skills. Experienced in Medical Device, Aerospace, and Engineering Consulting Industries. Successfully performs in remote work environment.

areas of expertise (alphabetical order)

Azure DevOps

Code Management Apps

Associate Training/Education (Compliance Wire)

GxP Regulations Document/Data Control, Records Management, Part 11 Esig / Erecords

Jira

MES (Custom)

MS Teams

Office 365 (MS office Suite, MS Project)

Office Timeline

Product Lifecycle Management (PLM) Systems

Project Documentation (throughout Project Lifecycle)

Project Management

Quality Systems Applications

Requirements Management

Risk Management

SmartSheet

Software Development Lifecycle (SDLC) – Waterfall, Agile, Hybrid

Supportive Leadership

Visio

SPECTRAFORCE, INC (CLIENT BCBS SOUTH CAROLINA)

SR. PROJECT MANAGER

07/18/2023 – 11/07/2023

Managed enhancement projects to meet customer needs. These included: claims process enhancements so that a sister company could route customer calls directly to representatives vs. sending them a customer service phone number, this project was delivered on time within budget. Implemented corrective measures for Explanation of Benefits (EOB) delivery to meet state regulation requirements.

Defined and created project plans.

Worked with teams to define tasks in Azure DevOps.

Managed project issues to resolution

Managed creations and submission of project deliverables through all project phases.

This was a short-term contract.

Insight global. (Client Gore, Inc.)

Cinci, OH

Sr. IT Project Manager

9/26/22 – 11/14/2022

Facilitated creation of project scope, goals, and deliverables that support project.

Defined and created project plan for project/program prioritization and implementation.

Building, leading, and coaching multiple project teams throughout project lifecycles.

Assessed and facilitated resolution of project issues as they were encountered.

Monitored progress and updated relevant business stakeholder status.

Began tracking milestones and deliverables using MS Project

Client cancelled the project and the contract ended.

Sharper Computing, Inc. (Client Ethicon Endo-Surgery, Inc.)

Cinci, OH

Sr. IT Project Manager

06/2018 – 06/2022

Managed multiple projects for R&D, Marketing, and Communications business units to bring efficiency and enhanced IT solutions to the business.

Developed program management deliverables to be used in strategic planning. Developed R&D project portfolio with links to individual project plans. Generated Risk Analysis for multiple projects. Created resource planning tool in Excel. Established Smartsheet project plans to standardize project schedules. Improved efficiency of R&D Teams through enhanced development of planning tools.

Developed marketing survey for physicians with Marketing team. Deliverables included leading multi-functional team to set up survey content and supporting analysis.

Assumed responsibility for cross-functional team to provide commercial data for Sales Reps to drive sales. Included developing project tools to focus team on project priorities, clarify scope, and establish a schedule.

Ethicon Endo-Surgery, Inc., (Johnson & Johnson)

Cinci, OH

IT Project Manager

04/2010 – 06/2018

Collaborated with business partners to create and gain approval on proposed Quality Systems IT projects. Enhanced and supported 8 critical Quality Systems applications, across 8 operating companies, in 10 countries. Managed support staff. Managed projects and applications including complex interfaces between ERP, Education/Training System, Quarantine, Electronic Batch Record, EtQ Instinct, Change Control / PLM application (Team Center), Records Management System, and custom MES using SLDC process. Maintained all project budgets and delivered on-time. These projects reduced the number of required Quality Systems Applications across the enterprise.

Maintained regulatory compliance for all critical Quality Systems applications with zero non-conformances or findings from internal company audits and external auditors (FDA, ISO).

Reduced total cost of ownership for Quality Systems applications by consolidating platforms and support services, decreasing apps from 20 to 3 (EtQ Instinct) and support costs 30%.

Initiated and led cross-functional assessment of critical MES Quality Systems applications, increasing uptime from 80% to 99%. Responsible for ensuring any issues were addressed immediately for these business critical applications.

Spearheaded development of divisional Quality Systems technology strategy approved by Quality Systems Vice President, leading to multiple projects improving efficiencies in multiple functional areas, including FDA market approval for Advanced PLM application for new complex device / drug delivery.

Led major platform upgrade for EtQ Instinct v11, Non-Conformance Reporting, CAPA, and Audits delivering on-time and below budget. This included cross-functional team members in U.S., Asia Pacific, and Europe.

Managed upgrade and enhancement projects for Quality Systems applications within budget and on schedule:

oAutomated MES batch release process, eliminating paper batch records and human error.

oRedesigned contract sterilization process and MES interface, resolving volume increase.

Ethicon Endo-Surgery, Inc., (Johnson & Johnson)

Cinci, OH

Quality Systems Technology Manager

02/2005– 04/2010

Responsible for Quality Systems, Change Control, Records Management (PLM), and Training systems both for Regulatory Compliance and Technology support and improvements. Maintained approximately 8-10 technology areas by providing business support. Led significant projects as Business Lead/Analyst on all Quality Systems technology projects. Projects spanned all Divisions, R&D, Ops/Mfg, Quality (Regulatory Compliance), Legal, Sales/Marketing.

Led major Quality Systems re-engineering project, including business analysis/mapping all QS Elements to applicable regulations/standards. This resulted in an overall reduction of policies/procedures by 30% and improved customer satisfaction. This was a pre-requisite for moving to a new document management system.

Managed project plan and business resources required to develop requirements, complete validation, and organizational change. Managed staff of 8 - 10 associates and contractors.

Managed analysis of all Reporting requirements for major transition to new ERP application. This required managing multiple off-shore and on-shore resources to streamline enterprise reporting from multiple data sources.

Planned and executed Mergers and Acquisitions for several companies and integrated into Ethicon. Focused on assessments of Quality Systems elements and applications including development and execution of transition plans. This required superior skills in dealing with associates, in some cases, under extreme pressure.

Ethicon Endo-Surgery, Inc., (Johnson & Johnson)

Cinci, OH

Senior Systems/Business Analyst

04/2003 – 02/2005

Assumed Lead role for Product Lifecycle Management (PLM), assessment and selection. Included leading a cross functional team and evaluating multiple vendors based on functional, business, compliance, security, financial, and support requirements.

Led all Change Control and Records application projects and implementations. Performed business process analysis and developed requirements. Implemented records management application converting and migrating thousands of Microfilm files to the new solution.

Acted as Validation lead, coordinating requirements and testing with multiple manufacturing sites for all Quality Systems projects.

Professional Development/Publications/Awards

Project Management Academy - PMP® Certification Training Completed 08/25/23 (Exam Pending)

Johnson & Johnson-sponsored training programs:

oAgile; GMP and GCP; EtQ Instinct; Team Center; SDLC; Non-Conformance; CAPA; Process Excellence Training (Green Belt Certified Black Belt Trained)

FDA 21CFR Part 11 Electronic Records and Signature: A Case Study, Regulatory Affairs Professional (RAPS) magazine; Requested to Present at Ohio Regulatory Forum in Columbus, OH

Received several Standards of Leadership Awards for Excellence in Project Delivery and Business Partnering

Education - University of Cincinnati

(Cinci, OH)

Bachelor of Science – Architectural Engineering

Associate of Science - Civil Engineering

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