Operations Manager with 21 years of leadership experience, and 31 years of manufacturing and development experience within the pharmaceutical and diagnostic industry.Achieved and maintained FDA approval for the Dartford site (three consecutive audits with zero observations) leading the construction of new facilities, enhancements of current facilities to exceed compliance requirements.Successful Audit facing representative (site generalist) during audit inspections by regulatory bodies (FDA and TUV).Achieved the highest internal supply rate within Abbott diagnostic division site to support internal and external customer needsImproved site Microbiological assessment and control through resource re-deployment and use of new technologiesSuccessful integration of the engineering department into operations to improve lead time and focus resources to manufacturing requirements Leadership and management of technical and non-technical reports (direct and indirect).Selection, recruitment, training and development of staff.Managing organisational changes and developing strategies to improve manufacturing efficiency lead times.Financial management of the cost centre.Successful integration of transferred processes into manufacturing facility.Site Disaster Recovery Manager.
Listed skills include Gmp, Biotechnology, Validation, Quality System, and 24 others.