Catherine Larkin

Background

About Catherine Larkin

Executive Global Quality Leader with 30 years of proven expertise driving organizational change and aligning multi-site quality initiatives across the pharmaceutical and biopharmaceutical industries. Passionate about developing colleagues and teams through coaching and mentoring, I bring a strong focus on Data Integrity, Governance, Quality Risk Management, and Contamination Control, consistently meeting or exceeding regulatory expectations. My extensive hands-on experience spans sterile drug product manufacturing, including Pharma, Biologics, and BioPharma, with a particular emphasis on Human and Veterinary Monoclonal Antibody production. I have a demonstrated track record of leading facility inspection readiness, conducting audits, and hosting regulatory inspections—achieving exceptional outcomes and positive results. I have held diverse leadership roles at site and global levels, including Qualified Person, Site Quality Lead, Data Governance Lead, Inspection Readiness Lead, and Quality Risk Management Lead. Previous experience working in a variety of site and global quality leadership/Director level roles including Qualified Person, Site Quality Lead, Data Governance Lead, Inspection Readiness Lead, Quality Risk Management Lead.