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Phil
Johnson
Senior Director, Quality and Compliance Services

Phil is a regulatory and quality-based professional with more than 25 years experience in the medical device, in-vitro diagnostic and pharmaceutical Industries. His core expertise is in the quality requirements for medical devices, diagnostics and pharmaceuticals including the writing, implementation and maintenance of quality systems, auditing of external suppliers and manufacturing/distribution sites, and due diligence auditing. He also has extensive experience in the application of post market surveillance systems for complaints management and vigilance reporting.

Phil provides strategic consulting to medical device, IVD manufacturers, distribution sites and corporate offices providing regulatory and quality support for global market entry requirements, including the setting up of logistics and distribution networks and the license requirements for these operations. He also provides regulatory and quality support for determining remediation and restructuring requirements.

Prior to joining QuintilesIMS in 2002, Phil was an independent regulatory and quality consultant and has held senior manufacturing and distribution positions in a number of medical device, diagnostics  and pharmaceutical companies. For ten years he was the founder and director of a UK Central Laboratory, providing world-wide IVD services to the pharmaceutical industry.

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