Nele OOMS

J&J
Head of Technology Quality Europe & Africa
With a Master in Bioscience Engineering and being a Certified Quality Expert, Nele Ooms has more than 15 years of experience in various quality and regulatory affairs roles in the pharmaceutical and medical device industry.
She started her career at J&J within Janssen R&D QA, where she had different roles and responsibilities over time, ranging from (pre)clinical auditor to finally being responsible for setting up a data driven risk-based audit program for R&D QA.
After 13 years, she exchanged the international pharma industry for a start-up, medical device software company, UgenTec. Under her leadership, UgenTec got ISO13485:2016 certified and their AI based software product got FDA approved.
Since 2 years, Nele re-joined J&J as head of Europe and Africa Technology Quality and Compliance.