Lean Quality Consultants
Lean Quality Consultants, LLC is a GMP consulting service provider with 30 years of experience in Pharmaceutical & Radiopharmaceutical industries.
We develop, execute, and evaluate GMP systems and provide training to enable our clients to better focus on their core business of discovering, developing, and manufacturing products that meet or exceed the needs of their customers. We provide Quality Consulting focused on technical understanding and LEAN Principles.
Our goal is to be a competent and reliable external quality partner to our clients. Our mission is to build relationships with our clients and improve their quality management systems and CMO oversight processes for increased value to their customers.
Frezewd (Frae) Kazmierczak, CEO
Stephen Sharples, IT Consultant
Frezewd H. Kazmierczak established Lean Quality Consultants in 2018 after a 30 year career. This includes 21 years at Eli Lilly and SRI International in quality assurance, laboratory technical support, and CMO oversight. Ms. Kazmierczak established and accredited laboratories, established and led cross company and cross disciplinary alliance teams for successful global launch of drug products, and led the development and execution of quality management systems.
Stephen Sharples has over 25 years of experience implementing strategic initiatives for companies in the Financial Services and Medical Industries. This includes HSBC, Hyundai, Encore Capital Group, LoanDepot and United Health. Projects includes custom software development, third party installations, system configurations and integrations, infrastructure upgrades, process improvement and mergers and acquisitions.