is a recognized expert in Life Science Compliance with more than 20 years of experience in the industry. For the past 13 years, he has led international compliance initiatives as CEO of GxP-CC, supporting organisations in implementing the strictest regulatory standards, including FDA and EMA requirements.
James holds an MBA from Colorado Technical University and a Certificate of Management Excellence from Harvard Business School. In addition, he brings deep expertise in cybersecurity, holding certifications as CISA, CISM, CRISC, CISSP, NSA IEM, and NSA IAM. This unique blend of compliance and cybersecurity knowledge enables him to help companies sustainably strengthen both, regulatory compliance and information security practices.
As a sought-after speaker and thought leader, James has presented at international conferences and supported organisations in more than 27 countries. He has implemented numerous strategic projects, supporting clients in strengthening compliance and operational excellence, and collaborated with thousands of experts worldwide. James is an active member of ISACA, PDA, DIA, and ISPE, and contributes to the PDA "Advanced Manufacturing and Applied Process Digitalization Interest Group".