The Director of Quality will work with a multi-disciplinary team in the development of radiopharmaceuticals. They will join an agile quality function and serve as the key point of contact for all GxP activities related to product development. The role: Lead the selection and qualification of CDMOs and vendors for the manufacture of IMP. Continue to partner with CDMOs and vendors to develop and improve quality. Work in close collaboration with CMC colleagues to oversee and support technology transfer activities from a quality perspective, in accordance with cGMP.
Provide Quality oversight across R&D projects and identify key risks and resource requirements. Contribute to the global manufacturing and business strategy. The individual: Experience in manufacturing and quality aspects of radiopharmaceuticalsExperience of interactions with regulatory agencies, (FDA, EMA and/or national EU agencies) including inspections and responding to review questions. Experience of technical transfer projects. Knowledge and experience of the clinical development process and GCP requirements is preferred
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