Philippa Johnson Email & Phone Number

An enthusiastic, highly qualified pharmaceutical professional with a strong scientific background with 30 years ’ experience in Clinical Supplies project management . A broad range of experience across a number of different therapy areas, development phases (phase I – IV) and geographical regions. Significant experience in regulatory agency inspections, strong leadership and communication skills and the ability to develop collaborative and effective authentic relationships. Operational Excellence Process Improvement – Green Belt certification• Label Process (facilitator and project lead)o Defined more efficient process for translation and label approval using electronic label approval system.o Reduced timelines for the production and release of multi-language booklet labels by 55 days. • QA release process Kaizen (participant)o Defined roles, responsibilities and relevant documentation required for QA release within internal electronic systemo Provided efficient communication between cross functional teams to ensure correct documentation is provided.• Temperature monitoring and excursion process Kaizen (project lead)o Defined robust process for temperature monitoring and excursion of IMP during shipment and storage at Investigator sites.o Defined roles and responsibilities for all activities internally and externally.o Formal process with defined roles and responsibilities for cross functional teams to ensure timely response for temperature excursions at vendors and investigational sites.Regulatory Inspections (GCP /GMP)• Core member for global internal clinical trial audits and regulatory inspections within Shire Quality Management Team • Supported follow up responses for all internal audits and regulatory inspections ensuring global perspective for clinical supplies.Prince2 Foundation and Practitioner Certification

Listed skills include Pharmaceutical Industry, Clinical Development, Clinical Trials, Gmp, and 13 others.

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  De Montfort University

  Pharmaceutical And Cosmetic Science