Erin Reichardt
Program Manager @Parzy Consulting
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WORK HISTORY
Program Manager @Parzy Consulting
Independent ConsultantManage Safety Data Sheet program, including triaging customer SDS requests and assigning work, driving to risk based decisions through program governance, and managing implementation of SDS authoring platform.• Reduced median SDS lead time by 51% through improved metrics and processes.
EDUCATION
Missouri University of Science and Technology
BS
SKILLS
ABOUT ERIN REICHARDT
I am a detail-oriented and organized Program/Project Manager and Quality Professional with extensive experience in the medical device and biopharmaceutical industry. I work collaboratively with global cross functional teams and have excellent verbal and written communication skills. I am accustomed to managing multiple items simultaneously and I am adept at maintaining clear communication with stakeholders at all levels. Regulatory compliance programs: I have managed Unique Device Identification (UDI) programs with a scope of 120 - 600 codes and budgets of ~$750k. I lead cross functional teams through the identification of printing and engineering solutions, labeling changes, and manufacturing implementation to ensure that product is available in market by the regulatory deadlines. Quality Systems programs: I have a proven track record of delivering transformational projects. I lead teams through improvement initiatives and deploy improved quality systems and business processes to enable timely decision making and manage operational performance. I have managed projects for Quality Systems integrations post acquisition, process improvements, and site closures.• CAPA• Change Control• Change Management• cGMP• Design Control• eIFU• Project Management Methodology - Project Initiation, Planning, Execution, Controlling, Closing• Quality Systems Improvement• Quality Systems Integration• Regulations, including 21 CFR 820, ISO13485, ISO14971• Risk Management• SharePoint• TrackWise• Unique Device Identification (UDI)I’m open to networking, consulting, and contract and full time positions. You can contact me at e••••••••@gmail.com.
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