I am a strategic, data-driven, compliance focused Senior Quality leader with extensive and proven success in the medical device, and biotechnology industry, specifically in global Quality Management System (QMS) implementation, biotechnology best practices (GxP), and Post Market Surveillance.I have developed, communicated, and managed the implementation of compliant QMS processes and systems resulting in positive results during external global regulator audits. I have proven the ability to communicate effectively with all levels of leadership and continually support the value of cross-functional collaboration.I have a passion for promoting quality within the culture of an organization successively with the goal of improving the lives of patients!Core Competencies: GLOBAL MULTI-SITE LEADERSHIP: Developed and implemented successful global complaint management, post market surveillance (PMS), and vigilance processes that comply with both medical device and laboratory regulations supporting a “One QMS” approach across multiple global sites. LEADERSHIP EXCELLENCE: Developed, chaired, and presented a monthly quality safety monitoring board for real time review of quality data metrics, potential risks, and trending. Cross functional senior leaders had visibility to customers and post market trending results enabling action to correct and/or prevent negative consequences which may affect the patient and/or business. INSPECTION READINESS AND AUDITING:I was a Certified Quality Auditor (CQA) performing internal and supplier audits at multiple stages in my career. I have a wealth of experience in inspection prep, management (front-room, back-room), subject matter expert (SME), and employee training for external regulatory audits. REGULATORY REMEDIATION (Consent Decree & Warning Letters):As the Post Market Surveillance subject matter expert, I developed and lead PMS remediation actions resulting from FDA formal actions. Actions included further root cause analysis, corrective actions, recall communication, response communication, and effectiveness confirmation.REGULATIONS & STANDARDS: FDA, EUMDR, IVDR, CLIA, MDSAP, ISOSKILLS: Strategic problem solving | Post-market Surveillance | Global regulations and standards | CAPA | Root cause analysis | Data analytics | Trending | Risk management | Internal auditing | Supplier auditing | Microsoft Office (Word, Excel, PowerPoint, Project, and PowerBi) | Trackwise, Salesforce, and Veeva Systems