Lisa Jazon

Background

About Lisa Jazon

My career has been focused on ensuring the implementation, management and oversight of robust, globally compliant Quality Systems, policies, and practices across all GxP areas. I have a proven track record of establishing practical solutions, that enable innovation, increase efficiency, support continuous improvement and ensure the delivery of safe and effective products in line with established and emerging regulatory expectations. Collaboration and communication are central to my approach as a team member and leader. I have effectively trained and developed both direct reports and cross-functional teams, building trust, capabilities, and productivity ensuring effective prioritization and execution of multiple concurrent projects in complex, fast paced, evolving environments. I have an analytical style that facilitates and enables alignment, data-driven decisions, solution selection, and implementation from both strategic and operational perspectives. Multiple teams have acknowledged and apprecaited my skill and expertise for accurately and concisely translating Subject Matter Expert (SME) input into technical documentation like system User Requirements, Investigation Reports, and Standard Operating Procedures, facilitating creation of necessary quality documentation. Technical Skills: Quality Management System | GxP Computer System Assurance and Validation | Data Integrity | Document and Records Management | Internal Audit | System Periodic Review | Vendor Qualification and Management | Regulatory Authority Inspections | Quality Management Review | Gap Assessment | Risk and Impact Assessment | Change Control | Deviation | Root Cause Analysis | CAPA | Continuous Improvement | SOP and Policy writing and review | System Maintenance and Administration | Training design and delivery | cGMPs, FDA, EU GxP, and ICH Selected Systems: Solabs eQMS| SumTotal LMS| DocuSign Part 11| Argus| Evidex| ServiceNow| Veeva| SharePoint| SAS| iSpring| Microsoft 365 (Word, Excell, PowerPoint, Visio, Outlook, Teams, Planner, OneDrive)