Michael Bruen

Michael Bruen has extensive experience in quality assurance and compliance, currently serving as a QA Supervisor at Alkermes since September 2011, where responsibilities include Change Management, Document Control, Technical Agreements, and APRs. Key projects include developing a new CAPA database, implementing an automated Document Management System, revising records retention strategies, and overseeing a scanning project for executed batch records. Prior to Alkermes, Michael held various QA roles at Elan Pharmaceuticals, including QA Compliance Supervisor and Systems Control Supervisor, and contributed to internal audits and KPI reporting. Michael's earlier experience includes positions at Wyeth Pharmaceuticals as a QA Documentation Analyst & Supervisor and at Sterling Drug as a Microbiology Analyst. Michael holds a 2.1 BSc Hons in Biochemistry and a Diploma in Industrial Studies from the University of Ulster, Belfast.