Director Of Quality Assurance
CurrentContinuing my evolution in the organization, I transitioned into the dedicated manager of the quality management system (QMS). I had been designing both structure and content while implementing most policies for the QMS since early in the manufacturing commercialization process. However, the increased scrutiny to the implementation of cGMP requirements in the manufacturing process required an independent Quality Assurance (QA) manager to ensure product integrity, industry standards and best practices are met, regulatory compliance, and minimize business and personnel risks. In this dedication position I meticulously overhauled all QMS documents for rigorous management review, greater process control, improved traceability, and minimized non-conformance. Furthermore, I took on the role of coordinating corrective investigations and root cause analyses to address identified manufacturing non-conformances.This role requires hosting regular onsite customer quality audits to demonstrate conformance to the established QMS. Audits were nearly universally seen as successfully with observations focusing on mutually beneficial improvements. I also monitor FDA guidance to ensure the manufacturing process is consistent with developing regulations for cell therapy ancillary reagents. I proactively contribute to the conversation on identifying critical process parameters and setting relevant acceptance criteria by regularly attending clinical conferences and publishing marketing material. The success of the organization is rooted in the ability to first understand the needs of cell therapy manufactures, and then deliver solutions that deliver their strict success criteria.
