Dr André Rieks is an accomplished biopharmaceutical quality leader with more than 25 years’ experience across global life sciences, pharmaceutical manufacturing, clinical & commercial operations QA, and enterprise quality transformation. He has held senior leadership roles in international organisations, where he has built and strengthened quality functions, implemented global GxP-compliant systems, led complex technology transfer and manufacturing programmes, and supported regulatory readiness across Europe, the United States, and Asia. His expertise combines strategic quality governance with hands-on operational delivery, supporting organisations through transformation, remediation, inspection readiness, and compliant commercial and clinical supply. 

• Global quality leadership, governance, and organisational transformation across multinational biopharmaceutical environments. 

• Enterprise Quality Management Systems, including QMS/eQMS implementation, governance frameworks, and cGxP compliance across EU, FDA, SFDA, and MHRA expectations. 

• Inspection readiness, quality remediation, regulatory compliance improvement, and audit preparation. 

• Clinical & Commercial Operations QA, GMP/GDP quality oversight, and compliant supply of investigational and commercial medicinal products. 

• Technology transfer, manufacturing scale-up, CMO oversight, and strategic partner management across international supply networks. 

• Operational excellence, change management, cross-functional programme leadership, and performance improvement.