publications Committee Biographies
Victoria Stace, Chair
Victoria is currently Director, Strategic Advice in Global Regulatory Affairs and Patient Safety Quality Assurance at AstraZeneca. She has 17 years QA experience working in the pharmaceutical industry at Contract Research Organisations and Commercial Investigator Sits across the GxPs. Victoria became a member of BARQA in 2002 and was elected a Fellow in 2011. She is current Chair of the Publications Committee having held previous positions on the Board of Directors, Editor of Quasar magazine and Conference Programme Committee member. She has a degree in Chemistry (BSc honours) and a Diploma in Research QA.
Claire van Leersum (Secretary)
Claire has worked in the pharmaceutical industry since 1986, originally in packaging and then in the laboratory. She has been involved in QA since 1990 in GCP, GMP, GLP and regulatory environments. She has many years of contracting and consulting for a number and variety of companies followed by several years as a Quality Manager and subsequently, Associate Director of QA in a large CRO.
In 2011 she set up CVLQA Ltd an independent QA consultancy and is currently working in both GCP and GMP environments.
Claire has been an active member of RQA (previously BARQA and QAG) since 1990 and has served on the GMP committee and the Programme committee. She has been a member of the Publications committee since 2008, where she is now secretary, and was involved in the preparation and review of the Outsourcing booklet.
Katarina graduated from the MSc programme in Quality Management in Scientific Research and Development run jointly by Cranfield University, Cranfield, UK and the RQA in 2013. She embarked on her journey of MSc studies in 2009, having already worked in clinical research for four years and quality assurance for one year. Her first degree is a BSc (Honours) degree in the subject area of mathematics and statistics.
Katarina's present role is with TMQA, a quality assurance consultancy providing support across all the GxPs, where she is responsible for their Central European operation. Previously, she held the position of a clinical quality auditor at Janssen, Pharmaceutical Companies of Johnson & Johnson. She started discovering clinical research and quality assurance within Phase 1 commercial organisations.
She has been a member of RQA since 2008 and has thoroughly enjoyed all the different aspects that RQA membership has to offer. For this reason, she has decided to become a more active participant in the Association's activities as a member of the Publications Committee.
Katarina's is presently based in the Slovak Republic and she endeavours to be an ambassador for the Central and Eastern European region.
Sarah Johnson has over 15 years’ experience in the bio-pharmaceutical industry. After graduating from the University of Sunderland with an Honours degree in Biomedical Science, Sarah gained initial experience in a central laboratory environment, progressing rapidly through CRA / senior CRA roles and Clinical Project Manager roles to become Head of Clinical
Operations at GFA and has taken on the additional role as Quality Systems Manager. Sarah has an extensive knowledge of the Clinical Research Process and the GFA Quality System. Her experience covers the monitoring and management of Phases I, II and III across many different indications. Sarah has a detailed knowledge of all aspects of regulatory compliance and REC / IRB requirements in Europe and the USA and has participated and hosted routine GCP MHRA inspections at GFA.
Pim is an experienced QA professional who is currently working for Julius Clinical as a QA Manager. Julius Clinical is an academic Research Organisation in the Netherlands. Pim has been there since August 2013 and previously worked for Kendle International (INC Research) for 13 years within quality. In the past he has done work for the Institute of Clinical Research in the UK where he was a member of the Phase 1 Special Interest Group. Pim attended Utrecht University where he obtained a Master of Science degree in Fundamental Biomedical Sciences.
Noel Kusotera is a Quality Assurance professional with over 20 years in the Bio-pharmaceutical and Life Sciences Industry and 17 years in Quality Management. He holds a Master’s Degree in Total Quality Management and Business Excellence from Sheffield Hallam University and a BSc Honors’ Degree in Biomedical Sciences from The University of Zimbabwe. He is currently working as an Associate Director, Quality Assurance for Novella Clinical – a Quintiles Company. He has a special interest in Strategic Quality and Quality by Design.
George is Senior QA Auditor at Chiltern International B.V., located in Leiden, the Netherlands. He is involved in GCP and GCLP audits.
George is a medical doctor with more than 12 years experience in clinical research and since 2008 held various position in Quality Assurance in CROs and also Pharma companies. Previous experience includes research assistant clinical pharmacology position at Clinical Emergency Hospital “Floreasca” Bucharest, Romania. He was briefly associated with the Romanian Competent Authority.
He has been a member of RQA since 2009, where he sits on the Publication Committee and is also part of the editorial team of Quasar.
Mary has been involved in clinical research for ~20 years in Project Management and Quality Assurance (18 years) in the US and the UK. She have worked at both CROs and pharmaceutical companies and has enjoyed the variety and diversity in both types of industries. She has been with a consulting company (ZigZag Associates Ltd) since 2011 and that milieu has provided a different set of interesting projects.
Mary's affiliation with RQA began in the 1990s after moving to the UK from the US (Chicago IL) and she has always found the status as a RQA member and as a Publications Committee representative to be invaluable as a GXP resource for information and individual contacts.
Paul is Associate Director, Clinical Quality & Compliance at Medimmune Ltd. (UK) where he is responsible supporting the Quality Management system within the Clinical Biologics division of Medimmune. He is also responsible for audit, inspection and vendor oversight support, and providing compliance advice and guidance.
Paul has 17 yrs experience in preclinical and clinical QA in the biotech, CRO, non-commercial and pharmaceutical industries. He has been a member of RQA for 14 years, where he sits on the Publications Committee and is also the current Editor of Quasar.
Pramod Wable is Manager, QA GCP/GLP at Daiichi Sankyo Development in Gerrards Cross, UK. He has been working in Clinical Quality Assurance for past 9+ years. Previous, he worked at ICON Clinical Research UK as a Senior CQA Auditor. This has involved working with global clinical QA team to developed harmonised audit process and procedures to support global clinical trials. Prior to this, Pramod has also worked for INC Research, UK (legacy Kendle International Inc) as a Quality Assurance Auditor where he was responsible for auditing, QA project support and assuring compliance with regulations and Good Clinical Practice.
Pramod holds a Bachelor degree of Pharmacy from University of Pune, India and a Masters in Pharmaceutical Science from Kingston University, UK. Pramod has published articles within index journals and spoken in international conferences on different subjects relevant to GCP, GPV and Quality Management Systems.
Pramod is trained Six Sigma Black Belt and currently finishing his doctoral research on Quality Management Systems in GCP in association with University of Florida.
Matthew is an experienced Quality Assurance professional with 10 year's industry experience. He graduated from King's College, London in 2004 with a PhD in Biochemistry and spent the next 4 years working in the NHS in Histopathology. In 2007 Matthew moved to Kendle (now INC Research) as a Regulatory Associate where he was responsible for Clinical Trial Applications as well as post-marketing management activities for a number of products. In 2010 he moved into Quality Assurance and joined PRA Health Sciences in December 2011. During this time Matthew was responsible for planning and conducting a variety of GCP audits, travelled widely and amassed audit experience in 17 countries within Europe and Asia-Pacific regions. He was also heavily involved in mentoring and training and hosted 2 MHRA GCP inspections and 1 EMA GCP inspection. He then moved to BTG, a pharma company specialising in medical devices and combination products, where he spent 2 years as a Clinical Quality Auditor. Currently, Matthew is based in the UK and is a GCP Compliance Manager with Boehringer Ingelheim. In his current role he is responsible for Managing the development and implementation of Quality Management processes, inspection readiness activities as well as managing non-compliance and CAPA systems. Matthew has been a member of the RQA since 2010 and joined the Publications Committee in April 2015.
Heather is currently the QA Director at Circassia Limited a specialty biopharmaceutical company focused on developing immunotherapies, where she is responsible for GxP compliance during the exciting times of Circassia recruiting subjects in to its first Phase III trial. Heather has over twenty years experience in QA, initially in the GCP, Data Management, Statistics and Computing areas but always keen to learn new aspects of QA. For thirteen of those years Heather enjoyed the varied and challenging life of a freelance consultant.
Chris has provided quality assurance, compliance, and computer validation consulting services since 2001, specializing in establishing data integrity programs, performing data integrity audits, vendor audits, providing training, validation, and implementing six sigma based quality improvement processes.
He has previously worked at Aventis Pasteur as Computer Validation Manager, working with GxP computerized systems. Prior to joining Aventis Pasteur, he worked at Johnson & Johnson’s McNeil Consumer Products Company in the National Quality Assurance Group and at Lancaster Laboratories.
He was a contributing member of the GAMP Laboratory Systems Special Interest Group, which published the guidance document on validation of laboratory systems, as well as a chapter chair for DIA ‘Peach’ guidance on computerized systems used in clinical research.
Chris is a Certified Six Sigma Black Belt, he has a Masters Degree in Quality Assurance and Regulatory Affairs and a BS in Physics and Computer Engineering. He was the previous President of both the New England Region Chapter Society of Quality Assurance (NERCSQA) and the Mid-Atlantic Region Society of Quality Assurance (MARSQA), and is currently the chairperson of the MARSQA computer validation committee.