Bio

Experience of international matrix management and senior management roles. Developing people, developing processes, effective best practice compliance, root and branch company reviews, gap assessments, organisational fitness assessments, regulatory strategies and development of growth strategies. Pharmaceutical: focus on product quality and patient needs to develop pragmatic quality systems based on mitigating risk. July 2017 Head of Inspection Readiness (Sanofi Biotech) 2014 -2017 VP Quality & Regulatory Implementing/maintaining Global policies and building a strong Quality team at all five sites, meeting EU and FDA standards and improving service to our customers. Four successful FDA inspections. 2012 Director cGMP Readiness - Crucell (part of J&J), Bern Inspection Readiness, Validation, 3rd party supplier management, Training development. Managed site turnaround projects to meet an FDA baseline inspection and 10 Swiss Medic inspections including closing all inspection CAPA from the previous 5 years. 2011 Head Quality Ops, Arrow (part of Watson). Building a quality team, hiring 60 QC staff, building a laboratory, reducing sample backlog, transferring 20 molecules. Interim Head Global Quality, Norgine Managing strategy for implementation of a Global Quality Team. Leading global compliance program and Incident management. Projects : improve access to medicines with UNICEF, WHO and Kenyan MOH. Quality Director at Merck, QA team leader at AstraZeneca. Global IT Head Validation at Roche Pharmaceuticals Led a team to deliver 2.5 million mosquito nets in remote areas of Kenya - 12 months later 30% less malaria. Global Business development Quality DHL Lifesciences supporting major customers. Pharmaceutical: FDA/MHRA etc inspection readiness, Management. Global, regional and local QA management and culture change. Expert auditor. cGMP - QA,QC, OOS, Incident Management, Risk based Validation - Cleaning, Process, Computers, Analytical, Equipment. Logistics