John Delaney

Proven pharmaceutical compliance leader with extensive GLP, cGMP compliance experience in the early development (pre-EIH, Phase I/II) formulation research environment. I am a subject matter expert in the areas of quality systems, investigations, root cause analysis, computer system validations, documentation, equipment qualifications, change control and training systems. Project management and leadership of cross functional teams in various areas of GxP compliance improvement, decommissioning of GxP manufacturing / laboratory areas, as well as technical supplies for preclinical and Phase I studies. I have wide-ranging technical writing expertise including qualification / validation documents, investigation reports and SOPs.