Experienced quality engineer, results oriented Senior Lead Quality& Validation Expert, experienced in managing diverse teams of technical and non-technical individuals globally to perform computer software and manufacturing validation activities in a regulated global environment. Passion for FDA preparedness and SOP process improvements. Expertise includes: * Managed 5+ years validation leads for Business Systems/IT systems validation on time &budget * Directed PMs within projects in PMM methodology processes delivered to meet UAT * Managing and mentored software development teams to complete their validation project deliverables, including validation, process validation but streamline approach * Managed over 25+ years activities covering quality systems in IT, Manufacturing, Automotive, Automation product testing, supplier quality by streamlining the quality management system. * Identifying and assessing risks to business areas and implementing procedures to mitigate negative impacts including business continuity. By following Risk Management delivered 100% systems without risks. * Acting member 4+ years on BQT for LMS, PMM Change Board, CSV Board, bringing simplification to the processes to achieve accurate results and projects on time. * Acting advisory of budget decisions for FGSQ supporting the cut of costs. * Lead the successful completion of Validation of SaaS, PaaS solutions (GxP) with attention to details and removing roadblocks * Completed Audit Response and remediation's of several internal GmP audits for IT Systems * Lead Audits for internal and external audits to reduce risk and simplify processes.
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