Aaron B•••

About

On the record

I am a Quality Assurance leader with extensive experience in GxP compliance, clinical and commercial manufacturing, and regulatory inspection readiness. My expertise spans GCP, GMP, and GLP, with a proven track record of building and strengthening quality systems, leading audits, managing deviations and CAPAs, and ensuring compliance with FDA, EMA, Health Canada, and ICH requirements. I excel at collaborating across functions, managing CMOs and suppliers, and executing risk-based quality strategies that drive operational excellence and safeguard patient safety. Directed external manufacturing and technical transfer activities for APIs, parenteral drug products, and extended-release tablets across global CMOs, ensuring supply continuity and regulatory compliance. Served as QA lead for NDA Module 3 submission, resulting in FDA acceptance of a novel brain imaging contrast agent. Led North American QA team for Phase and commercial vaccine programs, managing deviations, CAPAs, PPQ protocols, and batch disposition. Conducted internal and external audits, qualified CMOs, and ensured timely closure of CAPAs to maintain inspection readiness. Implemented IQ, OQ, and PQ validation protocols to qualify manufacturing and inspection equipment, supporting GMP compliance and regulatory filings. Supervised and mentored QA Specialists, Batch Record Reviewers, and Quality Coordinators, strengthening team capability and performance. Executed risk-based remediation projects aligned with evolving regulatory expectations, achieving positive audit and inspection outcomes. Improved aseptic filling, packaging, and automated inspection operations, generating measurable efficiency gains and cost savings. My core strengths include quality systems management, clinical trial compliance, supplier and CMO oversight, change control, deviation management, CAPA management, sterility assurance, batch record review, risk-based audit strategy, and regulatory inspection support. I am proficient in industry-standard tools including Veeva, SAP, TrackWise, Oracle, LIMS, Electronic Batch Records, Microsoft Office Suite, SharePoint, and audit management systems. I am passionate about advancing global health through rigorous quality oversight, regulatory compliance, and collaboration. I am dedicated to enabling the development, approval, and commercial supply of innovative therapies that extend and improve patient lives.