Vicki Young

About Vicki Young

Industry Leader in Quality and Compliance. Highly accomplished across a broad area of expertise in Pharmaceutical and Medical Device Quality and Compliance with experience in a manufacturing environment. Outstanding leader who builds and develops talent and high-quality teams through a mentoring style leadership. Leads project teams for remediation of compliance and Quality Systems. Achieved consistent recognition and promotions throughout career. Excellent strategic vision and planning, consistently resulting in highly successful new product launches and market demand. Excellent record of success in major FDA, DEA, MHRA and internal audits.• Extensive Project Management experience for example Compliance Action Plans, FDA Preparation and Quality System Implementations• Managed the Technical Documentation organization using Information Mapping and Visio skills• Improved department processes as in flow, trace-ability and cycle time through DMAIC methodology• Systems expertise in TrackWise, JD Edwards, Livelink, QUMAS eDocCompliance, Pilgrim SmartSolve, Labware LIMS, Microsoft Office Suite, Visio

Experience

1. Independent Consultant

   ALKU

   Mar 2017 — Present

   ALKU, Andover, MAQuality and Compliance Consultant (2014 – Present)Provided contract services in the following area.• Ft Worth, TX (09/2018 to 02/2019) – Performed retrospective OOS investigations to include root cause analysis, risk assessment, and CAPA plans for 83 lots of product. Revised ten site procedures to improve the overall system of investigations, deviations, atypical events, complaints, and failures.• Daytona, FL (06/2018 to 08/2018) – Quality support in preparation of regulatory inspection in areas of change control, product release, investigations, and CAPAs. Performed third party review for release of OTC products. • Ft Worth, TX (02/2018 to 05/2018)- Remediation efforts to align site to response commitments following a regulatory inspection. Performed site audit and third-party review and release of OTC product. • Rosemont, IL,(02/2018 to 02/2019) – Remotely acted as interim Quality Systems Manager at a divisional level for a large contract manufacturer. Facilitated the document change control process, reviewed, revised, and implement divisional policies and procedures across seven sites. • Danville, IL,(08/2017 to 02/2018)- Quality support in preparation of regulatory inspection where zero observations were noted. Focus was on the reduction of open investigations, CAPAs, and change controls. Implementation of quality tools to enhance writing, understanding, and effectiveness of thorough investigations and CAPAs. • Remote (3/2017 to 06/20/17) – Project Coordinator Supported the development of a Microsoft Project tool to assist with the tracking and metrics of regulatory filings worldwide.

Education

• University of Phoenix

  BS, BM