Lead Project Manager
CurrentLead project manager on multiple high profile, high dollar, large and complex FDA remediation and enhancement projects on medical devices.Direct all aspects and phases of the project lifecycle, including planning, coordinating, executing, monitoring, controlling, and closing all phases and all aspects of projects.Lead, mentor, monitor and manage a team of project managers.Perform Quality Reconciliation on completed field action projects ensuring all objective evidence is in a comprehensive format that follows internal and FDA documentation requirements and provide closure letter and package to FDA.Manage logistical planning of thousands of customer upgrades at hospitals nationwide. Facilitate and lead conference calls with Hospira personnel, upgrade technicians, and hospital contacts to plan and communicate project details.Act as primary liaison for Account Management, IT, Sales, Contract Management, Operations Management including close communications with Directors and VP's.Manage high volume of communication both verbal and written from project managers, team members, management and customers via phone, email, reports and in person.Perform all required managerial duties including written evaluations, time card approval, resume screening, candidate selection, and disciplinary action as needed. Perform all Project Management duties including progress and inventory tracking and reporting, develop Standard Operating Procedures, and ensure upgrades have been documented per FDA requirements.