Katarina Thor

Senior Consultant, GxPAssure

As a former Health Authority inspector, Katarina has conducted sponsor, vendor and site inspections globally for EMA, WHO and MPA including joint inspections with FDA. She has worked with all clinical trial phases and companies of all sizes. Both as a GCP specialist, advisor and auditor, she has conducted due diligence evaluations and participated in acquisitions.

Katarina has shaped quality and compliance functions internationally as a global pharmaceutical leader, delivering strategic initiatives and operational support in areas such as GxP quality, audits and inspections, R&D, IT, Phase I units and M&A integration. Always with a risk-based mindset. She is recognised for her rare blend of strategic vision and hands-on expertise in clinical quality and compliance which gives her a unique perspective on the challenges and opportunities across the industry. Global GCP audits, sponsor/vendor/site inspections and mock inspections across all clinical trial phases

• Health authority inspection expertise from EMA, WHO and MPA, including joint inspections with FDA
• Clinical quality and compliance strategy, inspection readiness, QMS development and risk-based oversight
• Due diligence, acquisitions, remediation, CAPA effectiveness and major quality event support
• Expert knowledge of ICH GCP, EU Clinical Trials Regulation, GDPR and digital/AI-enabled clinical trial guidance
• Designed and implemented global risk-based compliance policies, inspection strategies and oversight controls, including major health authority response support and compliance alert leadership
• Advised quality management on remediation, serious breaches, fraud/scientific misconduct investigations and GxP risk mitigation
• Languages – Swedish (native), English (full professional proficiency), French (basic professional proficiency)