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. 
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 Notable Contributions 

• Established and led Global Clinical Operations QA at BioNTech SE, supporting compliant manufacturing and supply for global clinical programmes. 

• Implemented global GxP Quality Management Systems and electronic QMS platforms, strengthening corporate quality governance and compliance oversight. 

• Contributed quality leadership supporting operations for the global launch of the COVID‑19 vaccine Comirnaty®. 

• Led EU-GMP-compliant technology transfer and manufacturing implementation across CMO networks in China and other international locations. 

• Delivered quality remediation, regulatory compliance, organisational restructuring, and operational improvement programmes across global pharmaceutical businesses. 

• Managed cross-functional technology transfer and manufacturing scale-up projects across Europe and Asia, improving operational efficiency and regulatory readiness. 

• Brings bilingual capability in German and English, supporting effective engagement across international teams, partners, and regulatory environments.