Kellie Macleod

Executive Vice President Global Quality Assurance

Worldwide Clinical Trials

Oct 2024 - Current (2 years)

• Lead the global Quality Assurance team at Worldwide Clinical Trials, a High Quality full-service CRO.
• Set direction and oversight for quality and compliance programs across clinical trials & Laboratory Services.
• Leverage over 28 years of experience in clinical trials, quality assurance, and regulatory affairs.
• Drive initiatives to enhance quality standards and ensure regulatory compliance.

MTOPRA - registered member

TOPRA The Organisation for Professionals in Regulatory Affairs

Mar 2014 - Current (12 years 7 months)

• Engaged as a registered member of MTOPRA within a global regulatory community.
• Monitored and adapted to the evolving regulatory landscape to enhance regulatory affairs practices.
• Collaborated with professionals to share insights and best practices in regulatory affairs.

Non Executive Board Member

Home Group

Aug 2023 - Oct 2024 (1 year 3 months)

A voluntary member of the Home Scotland Board (charity)

Executive Director - Operational Quality and Compliance (CDSD)

PPD

Jul 2021 - Oct 2024 (3 years 4 months)

• Led and developed a high-performing team of Clinical Research Professionals at PPD.
• Spearheaded operational quality and compliance initiatives including a successful eTMF Process improvement Program and Executive Quality Review and Action
• Ensured adherence to GxP and regulatory affairs, enhancing clinical research and laboratory processes.
• Drove complex clinical research and quality operations as a certified Black Belt, implementing process improvements.

Senior Director, GCD- Process & Systems Optimization/ Study Start up

PPD

Oct 2018 - Jul 2021 (2 years 10 months)

• Led a high-performing team of directors managing significant portfolios for key client partnerships.
• Provided strategic direction and fostered a high-performance culture through effective leadership and coaching.
• Oversaw the development and deployment of systems, processes, and policies to meet site activation service targets.
• Finalist in the TOPRA regulatory awards for contributions to regulatory intelligence during the COVID pandemic.

Director Regulatory Affairs

PPD

Apr 2017 - Oct 2018 (1 year 7 months)

• Led regulatory oversight for general medicine, oncology, and CAR-T cell therapy, ensuring compliance and strategic alignment.
• Served as the medical device lead and subject matter expert, managing a large regulatory affairs team.
• Acted as the primary executive contact for clients, facilitating regulatory authority meetings, scientific advice and Marketing Applications.

Associate Director Regulatory Affairs

PPD

Feb 2015 - Apr 2017 (2 years 3 months)

Senior Manager Site Activation

ICON plc

Jan 2013 - Feb 2015 (2 years 2 months)

• Monitored budget, bidding, resourcing, and leadership as the alliance partnership lead.
• Managed critical asset platforms, ensuring quality and customer satisfaction across large study portfolios.
• Interpreted country-specific regulatory requirements to expedite study start-up and reduce cycle time.

Global Study Start Up Team Lead

ICON plc

Sep 2011 - Jan 2013 (1 year 5 months)

Lead CRA and Activate Team Lead

Chiltern International

Oct 2007 - Jan 2011 (3 years 4 months)

CRA II/ Core Team Lead

Johnson Johnson

Jan 2004 - Oct 2007 (3 years 10 months)

• Monitored clinical trial sites to ensure compliance with study protocols and regulatory requirements.
• Trained and supported site personnel on study procedures to enhance data integrity and patient safety.
• Acted as the primary liaison between the sponsor and trial site, documenting monitoring visits and reporting findings.

Manager - NE Scotland Research Ethics Committees

NHS National Services Scotland

Dec 2001 - Dec 2004 (3 years 1 month)

• Managed the North East of Scotland Research Ethics Committees, overseeing departmental budget and resources.
• Provided leadership and line management to a dedicated team of support staff.
• Acted as a Scientific Advisor, ensuring ethical compliance in research initiatives.

Royal Army Medical Corps (Reserves)

British Army

Aug 2001 - Jan 2007 (5 years 6 months)

Territorial Army. RAMC then RAGC.

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Kellie Macleod

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