Dr. Hedinn Valthorsson

Developed and implemented a Third Party Risk Management process to evaluate Business Continuity capabilities of external manufacturers and services. Implemented a harmonized risk management process across all Novartis units, including methodology to identify Business Continuity related risks and mitigate them. Led several risk workshops in different countries. Conducted BCM and NEM audits, and developed improvement measures with the audited organization.

Responsible for all QbD / PAT activities in Pharmaceutical Operations in Switzerland, including Sterile Manufacturing, BioPharmaceuticals and Solid Dosage Forms. Combine Operational Excellence with QbD and PAT, creating real Continual Improvement opportunities by creating regulatory flexibility for products and processes. Compliance expert, Working as part of a two man team taking full responsibility for quality assurance aspects of new product launches for the entire organisation.

Took responsibility for all aspects of the process from granulation to final packaging and testing. Led a multifunctional team comprising 70+ operators and engineers. Delivered targets and key performance indicators. Drove Lean production and Continual Improvement to remain competitive while maintaining regulatory compliance. Implemented Quality by Design (QbD) / Process Analytical Technology (PAT) into existing manufacturing processes (Real Time Release approved by regulatory authorities)

Coordinated activities of a global team of +30 people. Developed a QbD strategy in tight collaboration with FDA (CRADA). Presented the Novartis QbD strategy to regulatory authorities (FDA/EMEA). Presented at multiple international conferences on QbD/PAT. Participated in ISPE’s PQLI team, publishing paper on QbD/PAT control strategy