Director Principal Consultant with PharmaLex. Quality professional with over 30 years’ experience in various Quality roles for several global (bio)pharmaceutical companies across a variety of platforms including Biologics, Sterile Manufacturing and Vaccines.. Holding a Masters in Pharmaceutical Microbiology from the University of Manchester. SME and auditor in Quality Management & Compliance, Sterility Assurance and Facility Design. Risk facilitator for QRM programs and experienced with management of complex investigations. Co- author of the PDA Technical Report no. 90 “Contamination Control Strategy”.