Alice Redmond

Vice President, European Operations
MBs, Project Management, University of Limerick (2001); PhD, Cell Culture, Dublin City University (1991); BSc, Biotechnology, Dublin City University (1987)

Alice Redmond is an experienced Regulatory Compliance, commissioning, qualification, and validation subject matter expert with 24 years of experience in the pharmaceutical and biotechnology industries. ~9 years of this time was spent working for Sandoz/Novartis in Basel. Kundl and Ireland. Significant experience with project planning, regulatory compliance, CQ and coordination. In depth understanding of aseptic processing, biotechnology products, oral solid dosages, liquid fill, Lyophilization, and medical devices. Understands FDA regulations, regulatory guidance documents, and ICH guidelines and applies product/process knowledge to develop risk based approaches. Experienced in Pharmaceutical Quality Systems, Manufacturing Excellence, and Regulatory Science initiatives globally. Significant experience in Compliance, QRM and QA Management, C&Q, and GMP compliance auditing of manufacturing facilities. Familiar with Lean principles and tools, Kaizen events, root cause analysis, visual workplace, Standardized work and process mapping.