Doreen Newhouse, MSc DN DI Consulting LLC

Doreen Newhouse is a GxP Quality and Compliance expert with 30+ years’ experience in local and global roles in support of GLP and GMP businesses. Her leadership roles have included quality operations for early-stage biotechnology products, technology transfers, facility startups, computer systems validation, inspection management and compliance oversight of Warning Letter remediation activities.

Her most recent career role was based in Germany leading a multi-year Global Data Integrity Program for the Sandoz division and subsequently for Novartis Pharma. Her responsibilities included strategic program management as well as direct engagement with cross-functional SMEs at sites throughout the global network for coaching, training, and problem-solving related to data integrity topics. Prior to this role, she was responsible for QA Compliance for the Sandoz Global Biosimilar & Oncology injectables business unit.

She is passionate about collaboration, kindness and quality culture excellence. She is particularly interested in contributing to efforts to strengthen quality culture through the lens of data integrity risk management. Ms. Newhouse earned a BA in Zoology from the University of New Hampshire and an MSc in Oceanography from Dalhousie University.