Runa Ulsoe GMP/GDP

I have an academic background with a Masters Degree in Natural Science (molecular biology and mathematics) followed by 4 years in research. After that I have spent 23 years in the Pharmaceutical Industry, First with Novo Nordisk then with UCB. Areas of expertise include: • Ensure compliance with regulatory requirements such as Annex 1 for DP • GMP/GDP auditing internally and externally of CMO/CLO’s, sterile manufacturers, DS manufacturing sites. • Governance of corporate quality systems including change control, development of training, Managing LEAN optimization processes, Project and people management Positions held/ Work experience 2016 - current: UCB Pharma SA, Belgium Global Quality Lead; Execution of internal and external global quality audits and setting direction for the UCB global Change Control system as Corporate Process Owner 2001-2016: Novo Nordisk A/S, Denmark 2015 - 2016: Team Leader QA packag-ing, Core CR-expert, cLEAN co-ordinator, GMP Lead Auditor 2012 – 2015: Sr. QA Professional - CMC Analysis, GMP Lead Auditor, CR Expert, Reference Material QA 2008 - 2012: Research/QA Scientist - CMC Analysis & Formulation QA 1997-2001: Research Center Risø, department of plant biology and molecular development