Qualified Person Services for Investigational Medicinal Product Manufacturing

NHS Blood and Transplant is seeking a qualified supplier to provide Qualified Person (QP) services for its investigational medicinal product (IMP) manufacturing programs. The supplier will support regulatory submissions, advise on manufacturing compliance for biological and advanced therapy products, and certify batches for clinical trials. Key responsibilities include reviewing regulatory and GMP requirements, input on manufacturing process design, batch certification, and staff mentoring. The Qualified Person must hold UK regulatory status and demonstrate recent experience as a named QP on a Manufacturing and Import Authorisation (MIA(IMP)) with proven batch certification experience. Experience with biological, biotechnology, cell therapy, and gene therapy products is preferred. The role requires approximately 24-48 days per year, with at least 50% of work performed on-site at NHSBT premises and the remainder delivered remotely. This is a regulatory and quality assurance role essential for maintaining compliance in investigational medicinal product development.