Virginia Vargas, PhD

Experience

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  GE Capital

  Oct 2004 - Oct 2006

  PMO -IT Program Manager

  • Managed complex integration of mission critical projects/systems, including project proposal development and project implementation. · Directed the planning, design, development, setup, and execution of applications including the move to over to the production support team. Provided Post -Implementation consultancy for the support team.· Managed expense and capital budgets. Performed ROI for every project and present to upper management, if business investment was favorable. Managed project development budget.· Proposed actions which can be taken to make the processes more efficient within the International start-up divisions. As a appointed Integration Leader, established synergies among common foundation among various business verticals.· Managed the interface with 3rd party vendors and external entities relationships as a basis of the product design. Show less

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  GE Healthcare HCIT

  Oct 2006 - Dec 2008

  Service Quality & Operations Program Manager

  • Partnered with all departments and Service organizations regarding customer concerns including enhancing and influencing customer’s features into existing product and services. Built culture of simplification and cost-reductions throughout the Business participation in Customer’s Quarterly Partnership Review meetings focused on partnership strategy for customer growth. Acted as primary liaison between GE and program partners, primarily GE Healthcare; balance needs of GE program partner, customers to ensure consistent high level of service is maintained.• Provided leadership of IIS Team to execute VCP/Productivity savings. Led Service End of Life global operating mechanisms with internal teams to ensure program-customer commitments are met. Built and promoted organizational change management initiatives, specifically to improve customer satisfaction.• Managed and promoted the use of Knowledge Management tools. Show less

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  General Electric

  Jan 2009 - Nov 2012

  - Improved GEHC IT Marketing’s Effectiveness through improved Data Quality & Technology. Supported process excellence goals, devising commercial data-technology strategy, execution roadmap and tactical deployment plans.- Provided functional ownership of GE Healthcare constituencies and thought leadership for allMarketing Data quality programs including the delivery and implementation of a Marketing Automation technology, which will enable a long-term sustainable marketing campaign management for the business.HIGHLIGHTS:Launched a Marketing Automation Tool technology significantly improving Marketing's infrastructure to support demand generation activities.• Integrated data & tools providing a platform to deliver effective campaigns, higher quality leads, tighterMarketing/Sales alignment & stronger funnel contribution. Expecting significant shift Sales time toselling vs. prospecting, shift Marketing time to revenue generating tasks, enhanced customer & prospect data & visibility to lead lifecycle.• Led effort w/ external vendor to close a significant gap. Completed a comprehensive data hygiene & duplication identification process. Effort led to significant quality improvement of IP customer data by 31% & lead/contact data by 45%.• Partnered with IT and was appointed Marketing's functional owner to help shape/support key processes including data remediation, defect management, data governance policies to meet goals Show less As a leader of customer experience, delivered world-class service and exceptional customer experience through the “development, execution and implementation of key customer loyalty propcess improvement programs. Managed several initiatives that resulted in exceeding customer satisfaction goals. Streamlined the availability of customer success metrics & drove visibility to top customer themes. Rigor enable teams to focus on key customer felt changes that led to an all-time high NPS (78%) & service satisfaction scores (80’s). Customer Retention efforts intended to protect our IB, revenue & customer relationships resulted in a notable retention improvement of 286% over '09. Customer Partnership reviews; a process driven customer engagement was re-engineered to strengthen customer relationships Show less

  • Marketing Program Manager, Commercial Data & Technology

    Apr 2011 - Nov 2012

  • HCIT Customer Excellence Leader

    Jan 2009 - Apr 2011
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  Baxter International Inc. via Avarent

  Jan 2012 - Jan 2015

  • Provided strategic guidance to the Global Regulatory Team for over 5K assigned products. Directed the development of Baxalta’s Regulatory Affairs electronic submissions framework and strategy. Successful planed-developed process steps and integrated roadmap and master plan to convert mandatory eCTD submissions. Met deliverables on time.• Led the execution of the Separation & Spin-off Program for Baxter Bioscience-related to the announced split of Baxter into two separate publicly traded companies. Drove program activities, functional Regulatory Affairs resource teams to ensure separation program was delivered on schedule, on budget, and met business objectives. Show less

  • Quality & Compliance Program Manager (FDA Remediation)

    Jan 2014 - Jan 2015

  • Strategic M&A and Integration Consultant, Medical Products/Bio-Surgery

    Jan 2012 - Dec 2013
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  Principal Strategic Independent Consultant

  Nov 2012 - now

  Independent Program Management Consultant & Advisor, Quality, M&A, Regulatory, IT Program Manager

  ** To discuss a project and availability, or request a copy of my resume - please contact me directly at 224-828-0712 or vargasv@yahoo.com. **Provide professional project/program management consulting services to Global and Chicago area clients. Retained as Senior Program Manager, either directly or through consulting companies, by leading companies including General Electric, Baxter, Baxalta-Shire, Abbott.Motivated achiever guides organization in applying technology and regulatory compliance to business settings, brings added value, and delivers solutions that support business strategy. Experience in managing complex, multi-level group, multi-disciplinary projects. Areas of specific expertise include:• Program / Project Management Strategy • Regulatory & Compliance. eCTD Submission Management• IT Automation, Integration for Merger & Acquisitions (M&A)• Separations for Organization Spinoff • Customer Experience, Voice of Customer Analytics • Quality Mgmt. System, QSR-FDA Compliance-Remediation, CAPA Process • Lean Transformation, Six Sigma, Root Cause Analysis• Leading Cross Functional Teams• Business Process Management (BPM) • Business Intelligence & Data Warehousing• ERP IT Implementations-Integration Sales Force, Siebel, CRM, Sales Tools, EMC- FileNet• Marketing Automation – Marketo, Eloqua Show less

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  Baxalta via NSF Avarent

  Jan 2015 - Jan 2016

  Strategic Regulatory, Spinoff & Submissions Consultant

  • Provided strategic guidance to the Global Regulatory Team for over 5K assigned products. Directed the development of Baxalta’s Regulatory Affairs electronic submissions framework and strategy. Successful planed-developed process steps and integrated roadmap and master plan to convert mandatory eCTD submissions. Met deliverables on time.• Led the execution of the Separation & Spin off Program for Baxter Bioscience related to the announced split of Baxter into two separate publicly traded companies. Drove program activities, functional Regulatory Affairs resource teams to ensure separation program was delivered on schedule, on budget, and met business objectives Show less

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  Quality Executive Partners, Inc. (QxP)

  Jan 2016 - Jan 2017

  Quality Compliance & Operations Program Manager (FDA Remediation)

  • Provided leadership of FDA remediation assessment & planning activities. Provided clear scope, a definition of the remediation needed. Establish a 12 workstream team structure and overall remediation strategy approach.• Assessed 11 years of documented enforcement history and compliance enforcement communications. Established top themes, current gaps and determined risks to level set the basics.• Collaborated with Executive Management to assess both systemic gaps and physical plant gaps for remediation needs and developed a comprehensive systemic remediation action plan to resolve the enforcement gaps and deficiencies.• Worked with appropriate subject matter experts to put in place necessary Interim Controls for several Quality Systems.• Rollout out of a comprehensive Project Management tools and mechanisms to support governance & reporting. Show less

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  Abbott

  Jun 2017 - Dec 2023

  M&A - Quality Regulatory Program Manager Consultant
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  CITADEL CONSULTING PARTNERS, INC.

  Nov 2021 - now

  Founder & Strategic Compliance Advisor

  Providing Strategic Regulatory, Quality, and IT compliance consulting for MedTech, Pharma, and Biotech industries.

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  Pharmatech Associates, a USP company

  Jan 2023 - Feb 2025

  Served as a pivotal liaison between PiSA Farmacéutica and Pharmatech, ensuring flawless coordination during critical FDA inspection and remediation processes, contributing to optimal client satisfaction, and building a foundation for future growth.

  • Strategic Regulatory & Compliance Program Lead

    Oct 2023 - Feb 2025

  • Principal Consultant

    Jan 2023 - Jan 2025