Biogen

John Johannesen

Head of GSRS Quality
Biogen

John Johannesen has over 25 years of experience as an engineer and quality professional working in both the medical device and pharmaceutical industries.  John is currently the Head of GSRS Quality at Biogen where he leads a quality team to provide quality support and guidance to the Global Safety & Regulatory Sciences department. Throughout his career, John has prepared for and hosted multiple inspections conducted by the U.S. FDA, EMA, and TGA.  Two of these during the Covid-19 Pandemic.  While at Biogen John has advanced the quality culture by mentoring the Safety and Regulatory department on quality principles, developing metrics to create visibility and drive accountability, implemented an audit & inspection readiness process, and implemented a global regulatory intelligence process.

John Johannesen’s Session(s)

— 3:00 pm EST
Undergoing Virtual Inspections: Expert Experiences and Guidance

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