Kellie MacLeod
Executive Vice President, Global Quality Assurance
Kellie MacLeod is an experienced professional with a diverse and extensive background in Quality & Compliance, Clinical Research, Regulatory Affairs, and Medical Genetics. With over 27 years of experience, Kellie is based in Scotland and has consistently demonstrated a passion for continuous learning and process optimization, holding a Lean Six Sigma Black Belt certification.
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Prior to Worldwide, Kellie served a notable 9.5-year tenure at her previous CRO, PPD, part of Thermo Fisher Scientific. During her time there, she led the Operational Quality and Compliance team, following leadership roles in Clinical Start-Up and Regulatory Affairs.
Academically, Kellie holds a Bachelor of Science degree in Biosciences with Chemistry, a Postgraduate Diploma in Laboratory Technology and Data Management, and a Master of Science (MSc) in Medical Genetics. She has a particular interest in prenatal diagnostics and CAR-T cell therapies and served as the scientific advisor for the NE Scotland Ethics committees. Kellie is an active member of the Research Quality Association (RQA) and a longstanding member of The Organisation for Professionals in Regulatory Affairs (TOPRA). Her contributions to regulatory intelligence, alongside her team, earned her a finalist position in TOPRA awards following the COVID-19 pandemic.
Before her career in clinical research, Kellie worked as a Laboratory Scientist specializing in Immunology, and Medical Genetics. She also served in the military with the Royal Army Medical Corps and Adjutant General Corps, where she acquired the unique skill of freefall parachuting. Early in her career, Kellie gained her initial clinical research experience at Johnson & Johnson (J&J), where she held roles as CRA I and CRA II and earned a Lean Six Sigma Green Belt certification. Her work in Diabetes research included specialization in both In Vitro Diagnostic Devices and Good Manufacturing Practices (GMP).
Kellie is deeply committed to her community, serving on the Home Scotland Board, a housing charity, and the Aberdeen University Program Advisory Board, where she provides guidance and support in the sciences and career development. Furthermore, she is a STEM Scotland Ambassador, promoting education in science, technology, engineering, and mathematics (STEM), advocating for Women in STEM, and participating in annual science weeks at local schools to inspire young learners.
