Wendy McGhee

Experience

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  NEW BREED LOGISTICS INC

  Sept 2010 - Sept 2014

  Quality Manager
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  Global Packaging Systems

  Sept 2014 - May 2016

  Quality Manager
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  FedEx Logistics

  May 2016 - Sept 2022

  Quality Engineer III
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  ISPE

  Sept 2022 - now

  Health Authority Outreach Manager - Regulatory Affairs

  The International Society for Pharmaceutical Engineering (ISPE) is a not-for-profit association serving its members by leading scientific, technical, and regulatory advancement throughout the entire pharmaceutical lifecycle. ISPE provides a neutral environment where regulators and industry can exchange knowledge to achieve common goals.Drive intelligence gathering on regulators’ areas of interest, looking for synergies with ISPE’s strategic goals. A persuasive communicator and have the composure and credibility to interact with government officials at all levels, exhibiting diplomacy, tact and professionalism. Essential Functions:• Support Sr. Director of Regulatory Operations in implementing ISPE’s Regulatory Engagement Strategy.• Build and maintain a strong network of contacts with key regulators and their support staff in ISPE strategic areas of focus, working with ISPE volunteers and Advisor Consultants as needed.• Work closely with ISPE conference and publications staff, serving as an informed resource for obtaining regulatory speakers and document reviewers.• Identify obstacles to regulators engaging as speakers, document reviewers, or becoming members of ISPE, which may differ from organization to organization, from agency to agency and from country to country. Work with the relevant ISPE staff teams on approaches to mitigate obstacles.• Working with ISPE’s regulatory volunteers, gather intelligence on regulators’ current interests/concerns/priorities using various means, disseminate relevant intelligence to ISPE staff and volunteer teams.• Contribute to the development of ISPE’s Regulator Database by identifying key regulators within global HAs, researching their respective expertise, and entering data as needed.Write, source, and/or review content for ISPE publications Show less