Clinical Quality Oversight has ended
avatar for Sharon Reinhard, M.S.

Sharon Reinhard, M.S.

Vice President, Global Quality
Experienced pharmaceutical executive with 23 years of industry experience, currently Vice President of Global Quality at AVROBIO, a gene therapy company based in Cambridge, with responsibility across all GXPs.   Previously served as Vice President of R&D Quality with CSL Behring where I had  responsibility for GCP, GLP, GVP, early GMP, and combination product quality as well as the QMS. Prior to that I spent 3.5 years working for Merck and 4 years running Clinical Compliance Solutions, LLC, offering right sized quality and clinical advice to a variety of small to mid-size companies. I have become a thought-leader in the area of GCP, risk-based approaches, quality by design and inspection readiness, having chaired and presented at more than twenty conferences during the past 10 years. I have worked on over a dozen NDA filings, supported countless regulatory inspections, conducted hundreds of audits and published over 20 abstracts and papers related to clinical research. My experience is comprised of a unique blend of roles in clinical development, operations, compliance and quality assurance across  all areas of GxP. I have worked in mid and large size companies, as well as start-ups. My undergraduate degrees come from the University of Pennsylvania in Biology and English and my Masters from Temple School of Pharmacy in Pharmaceutical Drug Development- Regulatory Affairs and Quality Assurance.
  • Timezone
  • Filter By Date Clinical Quality Oversight Sep 27 -29, 2021
  • Filter By Type
  • General Session - Live Streamed to Virtual Audience
  • Interactive Workshop - In-Person Only
  • Networking!
  • Track A - In-Person Only
  • Track B - In-Person Only