I have broad and deep expertise in CGMP, GCP & GLP, GPV. Partnering with the C-suite (CEO/CFOs), I have built quality organizations from the ground up for early stage (phase 1 & 2) and late stage (phase 3) drug development companies leading to marketing applications, product approval and commercialization, bringing two multi billion dollar products to market. With my ability to zoom in and zoom out to oversee all aspects of Quality functions, I contribute strategically and operationally. I have successfully managed and hosted six successful inspections including FDA and EU pre-approval inspections.
Proven track record in cultivating quality culture, building robust Quality organizations and quality systems in support global clinical trials, manufacturing and drug development. Thought leader with numerous presentations, technical publications, and professional affiliations. Active member of DIA (DIA GCP core committee member, and co-chair of DIA GCP working group).
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