Consultant, Pharma Biotech

Phone: +44(0)1751 432 999
Country: United Kingdom

Elaine Vandenberg has over 25 years’ experience in pharmaceutical R&D and manufacturing, including 21 years in increasingly senior roles at GlaxoSmithKline. As a senior quality leader, she has led departments and guided global teams to achieve quality and compliance in challenging situations. She has led remediation efforts for products, systems and departments and has coached teams and individuals to understand and comply with new regulatory expectations. Dr. Vandenberg has worked with manufacturing sites and laboratories internationally to deliver sustainable solutions to quality and technical problems and to coach personnel on implementation excellence and appropriate decision-making. She was responsible for setting global standards at GSK for products and processes and for providing education and coaching to manufacturing sites in order to meet the standards.

Dr. Vandenberg holds a BSc in biochemistry and a Ph.D. in analytical chemistry from the University of Toronto. A published author of numerous scientific publications, Dr. Vandenberg also holds two patents and has been a guest speaker at scientific conferences in North America and Europe. She has taught chemistry at the University of Toronto and Seneca College.

Her areas of expertise include:

  • Investigations and deviation management
  • Risk-based decision-making
  • Data integrity
  • Regulatory inspection readiness
  • Change control
  • Contamination assessment and prevention
  • Laboratory operations