Manager of Regulatory Compliance Services
John Steichen, RAC, joined the Safis Solutions team in early 2007. As manager of regulatory compliance services, he evaluates clients’ quality systems and cGMP/cGLP/cGCP compliance status and develops regulatory submission documents for device and drug companies. He has developed quality systems for life science companies, and regularly performs cGXP audits and vendor assessments globally. He is adept at 820, 13485, 210, 211, 58, Q7a as well as the cGCP regulations. As a previous manager of a QC laboratory, he has deep expertise in QSR laboratory controls including qualification of systems, protocol development/execution, and data management. Steichen is skilled in product development, vendor qualification, third party organization audits, SOP implementation, validation protocol development and execution, as well as 510(k), IND, NDA, and ANDA regulatory submissions. His 30+ years of experience range from chemist to QA/QC manager and several other technical positions. He received a B.A. in Chemistry and Biology from Concordia College.