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Leonard Steinborn
Senior Consultant

Mr. Steinborn is a Senior Consultant with Globepharm Consulting specializing in GMPs and QSReg matters relating to quality control and quality assurance in the medical device, diagnostic product and pharmaceutical industries. In addition to his extensive working knowledge in Good Manufacturing Practices, he is an ISO Certified Lead Auditor.

During his 20 years at Abbott Laboratories, holding progressively senior management positions, he devised, managed and led programs to assure compliance to drug GMPs and medical device Quality System Regulations internationally within the organization. Key positions in auditing, document control, training, supplier quality assurance, validation and contractor management have enabled Mr. Steinborn to provide efficient, and cost-effective leadership of these programs.

As Director of Quality Assurance for Searle Laboratories, he was responsible for all facets of quality control and quality assurance for a facility producing tablets, aerosols, suppositories, time-release capsules, medical devices and small volume parenterals. He successfully managed multiple US FDA NDA/ANDA product approval inspections, annual inspections and DEA (drug enforcement agency) controlled drug inspections.

Mr. Steinborn gained his experience from the ground up, starting as a laboratory technician and advancing through quality engineering, validation and auditing positions to manager and director levels. Individual contributor successes led to supervisory positions in pilot plant production, government contract review/approval, complaint handling, incoming inspection, change control and supplier qualification. As a manager, he developed auditing, document control, third party, incoming quality assurance and supplier/contractor control systems in their entirety for world-class companies as Hollister, American Hospital Supply Corporation, Searle and Abbott Laboratories.

As well as being a prolific author and presenter, in 1984 he authored the internationally acclaimed text “GMP/ISO Audit Manual for Healthcare Manufacturers and their Suppliers”, now on its 6th edition.

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