currently working at Boehringer Ingelheim Quality Medicine as Senior Compliance Manager and key accountability is to drive QMS implementation in the Medical organization. Before joining BI, I have more than 10 years’ experience in clinical operations starting from CRA and progressing to project manager and people leader, at both MNC pharma and global CROs.
Sharon Reinhard has over 20 years of industry experience comprised of a unique blend of roles in clinical development, operations, compliance and quality assurance. She has worked for large companies such as Wyeth, mid-sized companies such as Shire and Endo and small biotech companies like Solstice Neurosciences and iCeutica.
Prior to joining the industry, Sharon spent 4 years working in academic research at the University of Pennsylvania. She has developed expertise in GCP, risk-based approaches, quality by design (QbD) and inspection readiness. During her career, she has supported 10 NDA filings, over a dozen Sponsor regulatory inspections and performed countless vendor, site, document and process audits.
Sharon has published over a dozen abstracts and articles related to clinical research. She has also served as chair and/or speaker at numerous industry conferences. She earned her undergraduate degree from the University of Pennsylvania in Biology and English and her Masters of Science in Pharmaceutical Sciences from Temple University School of Pharmacy. In 2014, Sharon transitioned to independent consulting to provide “right-sized” clinical development and QMS services to a variety of pharmaceutical and biotechnology companies. In November, 2018, she joined Merck in the Quality Assurance division after supporting the company in a consulting role the previous 2 years.
