Brussels Metropolitan Area
With advanced degrees in Drug Development and Industrial Pharmacy from KU Leuven, I currently serve as the Central Site Qualified Person at Galapagos. My role involves establishing CAR-T quality systems for investigational cell therapy products and acting as a Qualified Person and Responsible Person for GDP. Core competencies include extensive knowledge in Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), continuous improvement, and expertise in pharmaceutical quality processes. At Galapagos, I collaborate with cross-functional teams, I aim to align organizational goals with regulatory standards. Motivated to contribute diverse perspectives, I focus on ensuring compliant and efficient systems that foster therapeutic advancements in a pragmatic way. With clear dedication, hard working and high intergrity, I am a true make-it-happener!
Setting up of the CAR-T quality systems for in house QP certification of investigational cell therapy products and act as QP.
Act as Qualified Person and Responsible Person for GDP. Key person to built the supply chain and quality processes for the succesful commercialization of the first commercial product Jyseleca(R) within Galapagos.
As QA supervisor and QP, I am responsible for the management of the quality system and subsystems for the operational department of Qualiphar.
As Project Engineer of the Chemical Lab, I was responsible for the support of the analysts in the performance and daily operational troubleshooting for a variety of (bio)-analytical techniques used at Pfizer Puurs (HPLC, UPLC, GC, Karl Fisher, AAS,...). Continuous improvement of routine analysis and the performance of equipment are key in the function.