Jade McFadden

Dynamic and results-driven Quality and Regulatory leader with over 14 years of experience leading high-performing teams across diverse industries including pharmaceuticals, clinical trials, medical devices, and forensic services.

A strategic visionary with a proven ability to drive organisational change, streamline operations, and ensure regulatory compliance across global markets. Adept at leading complex quality initiatives, fostering a culture of continuous improvement, and aligning business objectives with rigorous quality standards.

Known for empowering teams, mentoring talent, and delivering exceptional results in both public and private sectors. Strong track record in building and leading cross-functional teams to achieve operational excellence and business success.

• Lead the Quality & Regulatory Affairs functions as a key member of the Senior Leadership Team, driving the development and execution of the UK and Ireland business strategy to ensure quality excellence across operations.
• Oversee the design, implementation, and continuous improvement of Quality Management Systems (QMS) ensuring compliance with GMP, GDP, Medical Device and Cosmetic standards.
• Named MIA and MIA(IMP) Licence Holder, including Head of Quality Control 
• Lead and mentor cross-functional teams to ensure seamless product development, scale-up to manufacturing, and distribution processes, fostering collaboration and innovation across departments.
• Direct regulatory affairs and ensure timely integration of regulatory requirements with joint ventures and external partners, guaranteeing adherence to local and international standards.
• Spearhead quality-driven operational improvements, with a focus on enhancing productivity, reducing waste, and ensuring sustainable business growth.
• Lead the execution of internal and external audits, ensuring corrective actions are taken and risk management processes are implemented to mitigate non-conformance and enhance compliance.
• Provide clear and strategic quality governance to senior leadership in alignment with corporate objectives and maintaining transparency with stakeholders.
• Mentor and develop high-performing teams within Quality & Regulatory Affairs, ensuring ongoing training in regulatory requirements, quality best practices, and leadership development to build a culture of continuous improvement.

MHRA Cogent Gold Standard Responsible Person - March 2023

• Active Pharmaceutical Ingredients (API) Auditing, RSSL – May 2023
• Auditing to Pharmaceutical Standards, RSSL – October 2022
• Good Clinical Practice (GCP) Investigator Site Training, ICH E6 GCP – March 2021
• Forensic Laboratory Management Course, UKAS ISO17025:2005 – September 2014
• Scene of Crime Training, UKAS ISO17020:2012 – June 2016
• Root Cause Analysis (RCA) Facilitator & Trainer, SOLOGIC – 2016
• Member, Research Quality Association (RQA) RQA – 2020 - Present