Speaker Details
PCMG is delighted to welcome a diverse range of speakers from across the global clinical development outsourcing landscape to join us in Berlin for PCMG26.
Simon Molloy
Executive Director, R&D Quality, Gilead Sciences
Simon has 25+ years’ experience in the GxP (GLP, GCLP, GVP, GCP) Quality and Compliance roles, and 30+ years’ experience in the pharmaceutical industry.
Simon Molloy is an Executive Director and member of the R&D Quality leadership team at Gilead Sciences. He leads a team of Functional Quality Business Partners, providing the primary point of contact for R&D Functional engagement with the Quality Management System at Gilead Sciences. A key part of this Functional Quality oversight role includes the risk-based mechanisms for Vendor Quality oversight.
Simon has successfully led the organisation through multiple inspections, including four MHRA GCP inspections. He also led the implementation of ICH GCP E6 (R2) and his team has been engaged with the implementation of the R3.
He holds an honours degree in Applied Chemistry and a Diploma in Industrial Studies from Nottingham-Trent University, and the BARQA Diploma in Research Quality Assurance from Anglia-Ruskin University.
Simon is a former member of RQA, from 1997 to 2023. He was an active member of the GCP committee from 2001 to 2018. During this time, he managed the interface with the PV committee and led several seminars/courses on ‘Safety reporting in Clinical Trials’.
Register now for PCMG26
As the leading event for professionals in Clinical Development and Clinical Research Outsourcing, PCMG26 brings together sponsors, service providers, and industry experts to exchange insights, explore practical solutions, and strengthen partnerships shaping the future of outsourcing.