Louise Mawer

Senior Consultant, GxPAssure

Louise Mawer is a highly accomplished Senior Consultant and Director at GxPAssure Limited, with over 25 years of experience in GXP compliance, auditing, and quality assurance across the pharmaceutical and life sciences sectors. Recognised for her expertise in Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Pharmacovigilance Practice (GVP), Louise Mawer provides strategic guidance, training, and global auditing services to commercial, non-commercial, and academic organisations.

Her career spans pivotal roles at leading regulatory bodies and industry organisations, including the Medicines & Healthcare Products Regulatory Agency (MHRA), where she served as Senior GCP Inspector and contributed to national and international inspection programmes, policy development, and regulatory guidance. Louise Mawer has led complex inspections, including those involving serious breaches and politically sensitive issues, and has played a key role in developing risk-based inspection strategies and accreditation programmes.

In addition to her regulatory background, Louise Mawer has held senior quality assurance positions at LEO Laboratories, Celltech R&D, Covance Laboratories, and Leicester Clinical Research Centre, where she managed and executed comprehensive audit programmes, developed quality management systems, and provided training and mentoring to industry professionals.

A sought-after speaker and educator, Louise Mawer is Chair of the European Forum for Good Clinical Practice (EFGCP) Auditors’ Working Party, a board member of EFGCP, and an active member of several professional associations, including the Research Quality Association (RQA), ISPE, and CDISC. She is a frequent contributor to international symposia, workshops, and training courses, and has co-authored industry white papers on risk-based approaches to trial master file management.

Louise Mawer holds a Post Graduate Diploma in Research Quality Assurance from Anglia Polytechnic University and a BSc (Hons) in Biology from The Open University. Her commitment to advancing quality standards and regulatory compliance continues to make a significant impact on the global pharmaceutical and research landscape.