Highly experienced strategic thinking executive level Quality Director, with broad experience across disciplines and a proven track record in Pharmaceutical Quality management Operational experience with previous held positions of Solid Dosage Manufacturing and Packaging managementPractical knowledge of all aspects of Quality Assurance ranging from auditing sites to GXP, managing QMS systems, QC laboratories through to product release as a Qualified PersonExperience in the manufacture and packing of solid dose, semisolid and sterile products, controlled drugs, potent formulations, API, IMP,medical devices and combination productsManagement of a large number of Regulatory inspections including MHRA, FDA, PMDA and other national agenciesManagement of the Quality aspects of a number of investment programmes for solid dosage manufacturing facilities including compression, granulation, coating and potent drug operations.Development of the Quality standards required for the successful launch of new products including Japanese supply.Successfully management of a number of preapproval Inspections for US supplySpecialties: Experience with controlled drug and potent drug manufacture at both API and finished product level.Organisational change and resource managementExperience of Quality Due Diligence as part of site acquisitions including quality, regulatory and technical agreements contract manufacturing and transitional processes.Has set up and managed a corporate group, from scratch, responsible for HSE and Quality governance