Abi has worked in the Pharma industry for over 25 years, serving in clinical development in both QA and operational roles. Her career started in clinical study monitoring and GCP auditing and evolved into roles that defined strategy around project management, process excellence and compliance in clinical development programs and in the use of RWE/RWD. She currently leads a team of QA associates in the oversight of GCP and PV quality in 60+ countries at Novartis. Abi holds a Masters in Management and is a Lean Six Sigma Blackbelt. She is currently a collaborator on the TransCelerate Audit Readiness Considerations team creating a set of recommendations for documentation of processes for programs using RWE/RWD in regulatory decision-making.