Biography

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Experience

As a senior Quality leader with extensive experience in Pharmaceutical R&D and Manufacturing, Elaine 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.    


In 2017 Elaine formed Vandenberg Quality Consulting, offering her expertise in pharmaceutical quality and analytical sciences to the pharmaceutical, biotech and related industries. Clients include Level 10 Consulting, NSF Health Sciences and RMC Pharma.   


Having held progressive senior Quality and Analytical roles with GlaxoSmithKline Pharmaceuticals and Allelix Biopharmaceuticals, Elaine has worked with manufacturing sites and laboratories internationally to deliver solutions to quality and technical problems. She implements sustainable systems to ensure work is correctly executed and consistent decisions are made. The majority of her international responsibilities have been achieved remotely, using electronic telecommunications to build relationships and assess the local situation.   


Elaine’s excellent judgement in assessing complex deviations led to her appointment as Chair of the Secondary Product Contamination Review Board at GSK with responsibility for ensuring consistency in decisions across more than 60 manufacturing sites. She has been responsible for setting global standards in GSK for products and processes and providing education and coaching to manufacturing sites in order to meet the standards.     

Qualifications

Elaine holds a B.Sc. in Biochemistry and a Ph.D. in Analytical Chemistry from the University of Toronto. A published author of numerous scientific publications, Elaine also holds 2 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 scientific association involvements include USP (Prescription/Non-prescription Stakeholders Forum) and Calibration & Validation Group (Executive Advisor).  


Read more about Elaine’s qualifications on LinkedIn: linkedin.com/in/elaine-vandenberg  

More about Elaine

Outside of the scientific realm, in 2017 Elaine is a Director for both the Professional Disc Golf Association (PDGA) and PDGA Europe. She acts as Advisor to the Board of Directors for the Disc Golf Foundation, a 501(c)(3) charitable organization. She has 5 Female Pro Open and 2 Female Master World Champion titles in the sport of disc golf and has been inducted into the Disc Golf Hall of Fame.  

In summary...

Known for her leadership through difficult circumstances and risk-based decision making skills, Elaine brings expertise in investigations, Regulatory inspection readiness, data integrity and change control.