Claudia Lombardo

GMP QA Compliance Consultant

Claudia Lombardo has over 30 years of experience in the biotech industry. Claudia is a change agent with repeated success in establishing and improving Quality Management Systems, (eQMS), building, supporting, and overseeing Quality Assurance and Quality Control activities, vendor audit management and inspection readiness.

In addition to her Quality experience, Claudia has a background in lean six sigma improvement initiatives geared towards operations efficiencies, cost reductions, innovation and improvement of cycle times. Claudia has built capability in LEAN/Six Sigma through execution of projects and mentorship for Lean Six Sigma belts.  Claudia has experience in Cell and Gene Therapy, Biologics, Pharmaceuticals and Medical Devices industry.

Claudia has worked for startup biotech companies developing phase-appropriate quality systems and documentation. Claudia is an energetic, collaborative professional with strong multi-tasking abilities and analytical skills, driving business transformation and growth.