Heike Roeder in her position as Lead Digital Transformation Quality Management System is responsible for transformation of documentation-based quality management towards data-driven digital solution. This transformation comprises the quality standards as classically defined in SOPs and respective quality knowledge.
Since many years she is industry influencer for digitalization and holistic transformation: “From document to data”. She is member of the board of directors of the Pharma 4.0 ISPE.
Heike brings in a wealth experience from 20 years in the Pharma Industry, in senior positions in various business areas, such as commercial production, supply chain, clinical trial supply, learning and process management, and quality management.
She graduated from the University of Düsseldorf (Germany) with a degree in Pharmacy and is certified as Lean Sigma Green Belt and as Change Coach for systemic changes.