Jesse Ahrendt is an experienced industry consultant with over 15 years of active engagement in pharmaceuticals, biologics, medical devices and biotechnology as a certified Quality Auditor and Quality Engineer. His areas of expertise include QA compliance, third-party vendor evaluation, cGMP manufacturing, quality systems and quality auditing including validation, deviation/CAPA/EC, auditing/mock inspection, supplier qualification and QMS/risk assessment/SOPs. Mr. Ahrendt is an accomplished quality assurance and manufacturing improvement innovation leader who optimizes organizational resources. He has spearheaded organizational strategic quality assurance, manufacturing, vendor quality and supply chain operation optimization.
Mr. Ahrendt’s work has included activity on most continents and working alongside many cultures creating and executing product and process validations per international compliance requirements. In addition, he has implemented new QMS systems and operational manufacturing programs into existing client portfolios, including the management, training and staff alignment portions of projects and qualification activities for multi-facility and multinational organizations. His background is extensive in continuous quality improvement, cGMPs, management principles, global regulatory guidance, and Lean, Six Sigma, QMS and QbD principles.