GxP-CC Global Leadership Team
James R. Francum
Mr. Francum is an executive officer and a visionary founding member of GxP-CC. His role within the company is coordinating the operations of all divisions as well as leading the company members and their partners internationally.
Mr. Francum’s extensive experience in the field of Information Security and in the Life Science industries puts him at the forefront of compliance management.
Under his leadership, GxP-CC has evolved to provide a broad range of services to the Life Sciences and Dental industries, including global compliance solutions to the leading pharmaceutical and medical device companies worldwide.
For over 15 years Mr. Francum has worked in regulated environments directing and orchestrating the various components involved in assuring compliance of the most stringent regulatory requirements. He is an internationally recognized expert and has extensive experience in over 25 countries including, but not limited to, the regions of North America, Latin America, Europe and the Middle East.
Zuhdi Hussein, PhD
As an executive officer and founding member of GXP-CC, Dr. Hussein’s role in the company is leading the sales and marketing division as well as driving the executive decisions concerning the company’s success.
His wide experience and success over the past fifteen years within the medical device industry has lead the company to success regarding regulatory services for QM compliance, process validation and equipment qualification.
Dr. Hussein developed and established the GMP Service Packages as a service portfolio for our customers. His wide experience helped him in developing innovative and customer- designed solutions in special areas such as cleaning validation for the medical device industry, utility validation and process validation methodology. Further packages include a supplier qualification package for the GMP manufacturer.
Dr. Hussein has over 15 years of experience in the GMP industry as a successful advisor for top medical device and pharmaceutical companies. In 2008 Dr. Hussein was named as an assessor for project management in the “German Society for Project Management” (GPM).
Dr. Hussein holds a Master’s in Physics and a Master’s in Biomedical Engineering from the University of Hannover in Germany. He also holds a PhD in Physics from the University of Luebeck in Germany.
Henry Macartney, PhD
Dr. Henry Macartney is one of the founding members of the company GxP-CC. In his role of Chief Financial Officer, he has been primarily responsible for the organization of financial resources and controlling, the cooperation and organization of the legal department, the organization of HR and he has been instrumental in the development of training in GxP-related topics. He has made innovative contributions to building up the company and in helping the company attain a high degree of quality, which we offer to our partners and customers.
Dr. Macartney began his career within the medical device and pharmaceutical fields where he was involved in research and development before moving to the central computer division of the company’s research division located in Upper Bavaria, Germany. In 1996 he started his career in the consulting industry.
An industry-wide recognized expert who has issued various publications supporting industry standards, Dr. Macartney is also referenced by the National Academy of Sciences.
He holds a B.Sc. degree in Biochemistry and Physiology from the University of London, a M.Sc. degree from the Queen’s University of Belfast (Biochemistry), and a PhD degree from the University of Bielefeld (Biochemistry).
Gerhard Hartmann, PhD
Dr. Gerhard Hartmann is also a founding member of the company GxP-CC. Dr. Hartmann began his career within the nuclear sciences field where he was involved in research and analysis of plutonium effects on organisms and the biosphere. Applying his vast experiences from the cross-industry quality standard methodologies, Dr. Hartmann moved into the Life Sciences sector in 1995.
Dr. Hartmann has been in the leadership role of multiple companies, including the board of directors, within his career. In total, Dr. Hartmann has gained over 18 years of industry- specific experience providing compliance solutions to 10 of 10 leading pharmaceutical companies.
Dr. Hartmann holds a PhD degree in Analytical Chemistry from the University of Darmstadt, Germany.
Mr. Reinhardt is the Vice President of Compliance Engineering and Development within GxP-CC. His role within the company is to manage world class engineering teams within the international assignments.
Mr. Reinhardt’s extensive experience in the Pharmaceutical and Medical Device Industry concerning regulatory services for Engineering Project Management, QM compliance, Computer System Validation, process and equipment validation provides our customers and our team members with dynamic and sound fact based engineering competency.
Through the engineering solutions that Mr. Reinhardt has coordinated and continually improves, GxP-CC has the ability to facilitate the investigative compliance products though out the entire life-cycle of our customers.
Mr. Reinhardt has worked over 20 years in regulated environments and has been in the leadership role for Engineering, Development and Project Management with managerial responsibility of various companies.
Mr. Reinhardt holds an equivalent M.Sc. in Electronic Engineering (Dipl. Ing.).
Jason N. Young
Mr. Young is the Vice President of Information Security Architecture and Engineering Services within GxP-CC. His role within the company is the coordination and integration of compliance, governance and risk concerning information security for our customers.
Mr. Young's experience in information and cyber security’s integration to existing enterprise quality assurance and information systems management structures sets him apart from his peers in building secure enterprise architectures that support core business operations. Through methodologies and technical solutions that Mr. Young has coordinated and continually improved, GxP-CC has the ability to integrate security into our compliance products at all levels of the enterprise.
Mr. Young has worked over 18 years in the private, U.S. federal government and military environments managing and engineering various security solutions.
He has also been heavy involved in creating structured methodologies for conducting vulnerability and penetration tests to validate network security architectures, as well as managing the network operation security centers for several regional areas for NATO. He is an internationally recognized and published expert with extensive experience in the North America, Africa, Europe and Asia/Pacific regions.
Mr. Young holds a BA degree in Business Administration from the University of Houston, and a M.Sc. degree in Information Assurance from the University of Maryland University College.
John Cullum, PhD
John Cullum, PhD is head of the Scientific Advisory Board. His primary responsibility is to recruit leading academic advisors as needed for the future development of the company.
After studying Mathematics, John Cullum, PhD moved into Molecular Biology and is now Professor of Genetics at the Technical University of Kaiserslautern, Germany. His research fields of Bacterial Genetics and Bioinformatics are relevant to the search for new pharmaceuticals, and he is involved in collaborations with pharmaceutical companies.
John Cullum, PhD holds a BA degree in Mathematics (University of Cambridge, UK), an MA degree (University of Cambridge) and a PhD degree in Molecular Biology (University of Edinburgh, UK).
Peter Hoh-Malewski, LL.D
Peter Hoh-Malewski is a senior managing partner of the joint law practice “Göhmann Rechtsanwälte” (Goehmann Advocates) in Frankfurt am Main. By profession he is a legal practitioner and notary. Dr. Hoh-Malewski is a leading member of the supervisory council for various companies and together with these duties is assistant professor at the Technical University of Berlin, lecturing on regenerative energy sources. Together with his team he accompanies, advises and represents us as our “external legal department” on all aspects pertaining to the law and concerning both our internal structure and our operative business.
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