RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Kellie MacLeod has joined Worldwide Clinical Trials (Worldwide), a global full-service contract research organization (CRO), as Executive Vice President, Global Quality Assurance, bringing over 23 years of extensive experience in clinical trials, quality assurance, and regulatory affairs. In this role, MacLeod will lead Worldwide’s global Quality Assurance team, setting direction and oversight for the CRO’s quality and compliance programs.
The pharmaceutical regulatory environment is constantly evolving, with increasing complexity and scrutiny from regulatory bodies globally, making it more important than ever for CROs to ensure compliance and the highest standards of quality and patient safety. Worldwide’s continuous focus on quality is a key contributor to its above market growth, demonstrated by the 2024 Industry Standard Research (ISR) reports in which Worldwide was *ranked the highest rated Phase I provider for Overall User Preference and the top CRO for Overall Performance in Phase II/III services, among high marks in other categories. MacLeod's experience and leadership in quality assurance and regulatory affairs will support Worldwide’s continued growth and partner-of-choice ranking through consistent delivery of high-quality data.
"We are thrilled to welcome Kellie to our executive team," said Peter Benton, President and CEO, Worldwide Clinical Trials. "At Worldwide, our consistent focus on quality has been a catalyst for our growth. Sponsors count on our rigorous study conduct and time-tested, fit-for-purpose methodologies that ensure data quality. Kellie’s deep expertise in quality management, regulatory compliance, and clinical operations will be invaluable as we continue to expand our global footprint, drive continuous process improvements, and deliver the highest quality clinical trial services in partnership with our customers to help patients around the world.”
MacLeod joins Worldwide from PPD, part of Thermo Fisher Scientific, where she most recently served as Executive Director, Operational Quality and Compliance. In this role, she led a high-performing global Operational Quality Team responsible for compliance with global regulations, policies, and procedures. She also oversaw the company's eTMF platform, improving quality metrics and collaborating with the CEO to develop an eTMF center of excellence. Prior to that, MacLeod held leadership roles in site intelligence and activation, process and systems, and regulatory affairs at PPD.
"I am excited to join Worldwide Clinical Trials and contribute to its mission of partnering with customers to deliver life-changing medicines to patients around the world," said MacLeod. "I look forward to working with the talented team at Worldwide to further enhance its quality management system and ensure the highest standards of quality and compliance across all operations."
MacLeod holds a Master of Science (MSc) in Medical Genetics from the University of Aberdeen and a post-graduate diploma (PgDip) in Laboratory Technology and Data Management from the University of Aberdeen. She is also a certified Green Belt in Lean Six Sigma.
Learn more about Worldwide’s industry-recognized quality assurance protocols at www.Worldwide.com.
* Findings from a quantitative survey of key clinical development outsourcing decision makers from small, midsize, and large biopharma companies.
About Worldwide Clinical Trials
Worldwide Clinical Trials (Worldwide) is a full-service global contract research organization (CRO) that works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Worldwide’s capabilities include bioanalytical laboratory services, Phase I-IV clinical trials, and post-approval and real-world evidence studies – all powered by an accessible team of clinicians, scientists, and researchers who bring first-hand expertise and a collaborative, personalized approach to each clinical program. Worldwide is therapeutically focused on neuroscience, oncology, rare diseases, and cardiometabolic and inflammatory disease. Its global footprint spans over 60 countries with more than 3,500 team members. For more information, visit www.worldwide.com.
