Keith Oconnor

Background

About Keith Oconnor

Greetings, I am a seasoned Quality Assurance Director with an impressive two-decade tenure. Throughout my career, I have consistently provided thoughtful leadership, assembling and guiding diverse and specialized teams to ensure adherence to Good x Practices (GxP) standards and provide strategic guidance on Chemistry, Manufacturing, and Controls (CMC) product development. My expertise in GxP implementation shines through. I have successfully implemented various software systems using GAMP5 guidelines to help bring big and small pharma companies into the digital age. Systems include eQMS (Veeva, ZenQMS, MasterControl), IRT (Endpoint Pulse, 4G IRT), EDC (Medidata Rave), Safety database (Argus) and eTMF (Veeva and Phlexglobal). Quality auditing is another area where I excel. I have lead over 150 audits across the GxP landscape, encompassing CROs (GCP and GLP), CDMOs (GMP), and CTLs (GMP and GCLP). My ability to identify gaps and recommend corrective actions has played a pivotal role in enhancing quality standards. As an Operational Quality Leader, I have overseen upstream and downstream production for Phase I to Commercial products, with a specialization in sterile parenteral production. My expertise in cleanroom qualification, aseptic techniques, media fills, and USP 71 ensures adherence to the highest quality standards. I am driven by a deep commitment to product quality and patient safety. I am eager to share my knowledge and experience with organizations seeking excellence in CMC product development and GxP compliance.