Antwerp Metropolitan Area
Senior Quality & Compliance Leader accountable for defining and executing the end-to-end R&D Quality Strategy across multiple clinical development programs in Oncology (ATMP) and Immunology.
Led R&D Quality across clinical programs, ensuring compliance with GCP, cGLP, GVP and GMP. Defined quality governance models, KPIs and management review processes. Oversaw QMS design, implementation, ad continuous improvement, including eQMS rollout. Partnered closely with ClinOps, RA, PV, CMC and Data Science. Managed and coached the R&D Q team.
Designed and executed risk-based quality monitoring strategies for clinical trials. Provided Quality Oversight across CROs and vendors. Supported inspection readiness and regulatory interactions.
Management of IMP in the framework of phase I clinical trials ; People management ; Qualified Person ; GMP activities
Management of the Quality System : CAPA, Internal + external audits, Quality Documents management, System validation, Complaint Handling