Tracy Lee Mitchelson is the Director, US Safety Governance CoE for US Medical Affairs at GlaxoSmithKline (GSK). In this role, she leads safety governance strategy across all business units (Pharma, Vaccines, Consumer Healthcare) to drive business value and build trust through a quality and compliant Pharmacovigilance (PV) System. She also leads the following risk management & quality activities: US Safety Risk Register, Management Monitoring and training plans; coordination of safety related assessments, internal audits, Regulatory Agency inspections, and CAPA tracking; author US Pharmacovigilance SOP; liaison for PV activities in US LOC Clinical studies and implementing new US regulatory requirements.
In her 16+ year career at GSK she has worked in a variety of roles in Clinical as well as improving operational effectiveness by leading process improvement projects across Pharma R&D. In her previous role, she was the Quality & Risk Management Director for the Dermatology Therapy Area.
In addition, she is also
- a Lean Six Sigma Black Belt and Accelerated Delivery & Performance (ADP) consultant and trainer
- an internal executive coach
- a member of the R&D Inclusion Council and Global Disability Council
- the founder and leader of the Disability Confidence Network Employee Resource Group (ERG)
- a member of the USBLN ERG/BRG Leadership and Executive Committees
- Past (2016) President of RTP Healthcare Woman’s Business Assoc (HBA)
She holds a Masters in Public Health (MPH) from the University of North Carolina (UNC) and a Bachelors in Business Management from North Carolina State University (NCSU). Her clinical experience includes her training as a Paramedic along with 8+ years as a volunteer at a fire department in EMS, Fire, Rescue and Hazmat.