Meet the Board & Committee

Jamie Toth is Global Head, Trial Master File Management & Records at BeiGene, home based in New Jersey, USA. Prior to joining BeiGene she was with Daiichi Sankyo, Inc., where she implemented global systems (eTMF, CTMS, Safety Notifications) and processes and was responsible for TMF Operations, clinical systems, and records management within the R&D space.

Dora is an Information Governance, Privacy and Compliance professional with over 15+ years’ experience of the pharmaceutical industry.

Dora has been a HSRAA Executive Committee member in various roles since 2017 having been responsible for publications coordination, held the role of the Chair of the Committee from 2019 – until Nov 2022, and currently serving the association as the Committee Secretary.

Bob is a GxP Archivist and has an Archives and Records Management Post Graduate Diploma from Dundee University. Bob has a background in programming and database administration, as well as knowledge and understanding of Computer Systems Validation.

Marion is a dynamic and inspirational leader in the Life Sciences space with 30 years of experience. She is highly skilled in developing and implementing enterprise-wide programs and technical systems in regulated environments and has a proven track record in designing, building, and leading cross-functional teams across multiple disciplines. Marion also has in-depth experience with quality and compliance processes in the pharmaceutical industry, focusing on supporting organizations through GCP regulatory inspections with FDA, MHRA, EMA, and PMDA. Her extensive experience in R&D, Clinical Research, Manufacturing, Quality Assurance, Records & Information Management, Quality Control, Operations, System Implementations, and Regulatory Inspections will greatly benefit HSRAA.

Pawel has worked in clinical operations for over 12+ years in various roles. In his current job, Pawel is responsible for implementing clinical systems, inspection readiness, records management, CRO oversight, and records archiving.

Ashely Avery is a Senior Specialist, Quality Documents and Archival at AbbVie. She is a skilled Clinical Trial Specialist II with over 5 years of leading clinical trials experience and an additional 5 years in Quality Records with knowledge across all phases of studies with proficiency in start-up and maintenance phases. She brings her skills of maintaining oversight of operational aspects to include quality control review of clinical projects, SOPs, and ensuring compliance with a track record of accuracy and exceeding deadlines.

Dr Benjamin Bader is the Managing Director at Z.A.S. Zentral Archiv Service as well as the Head of archiving working group at GQMA, German Quality Management Association. Benjamin brings 15+ years of pharma service and life science background into the HSRAA. He obtained his PhD at the University of Rostock (Germany) and Karolinska Institute (Stockholm) and worked in preclinical contract research in different leading positions before he was appointed as CEO at ZAS in 2018. He is responsible for the GLP test facility management and the director of manufacturing within the manufacturing authorization of ZAS. Furthermore, he is in the extended board of the German Quality Management Association e.V. (GQMA) and is heading the archiving working group. He is co-author of the GQMA manuscript on “Electronic Archiving in the GxP area” and invited public speaker on several national and international conferences.

Michael is a Sales Professional and Project Manager with a focus on the Life Sciences industry which includes: CROs, CMOs, pharmaceutical, biotechnology and medical device companies. He has experience in automating business processes to ensure regulatory compliance, increase productivity and accountability. His interest lies in bringing innovative solutions in the form of repeatable and high-value combinations of technology and services in response to the diverse business and regulatory needs of the life sciences industry.