A tactical and results oriented Quality Systems professional with proven success in creating and deploying compliant Quality Management Systems under fast-track conditions and achieving ISO/EN certification and/or FDA registration on first pass.
Experienced in: Forming departments and deploying compliant quality systems for a broad range of Medical Devices, Diagnostics, Biologic, and Life Science Products (dPCR, Genomics, Targeted DNA Sequence Enrichment). Planning and implementing Quality Systems strategy – QS Deployment Integration and/or Separation Projects. Manage third party audits by FDA, European, and Corporate auditing bodies. Performing Quality Systems due-diligence on Merger & Acquisition projects. Ability to effectively connect to drive change management within a matrix and diverse organization and with business partners. Manage Contract Manufacturing Organization (CMO) selection and compliance.