Batch Release Leader

il y a 2 semaines


Gent, Flandre, Belgique Proclinical Staffing Temps plein
About the Role
We are seeking a highly skilled professional to lead our Commercial and Batch Release team. The successful candidate will have extensive knowledge of GMP within a biopharmaceutical context and be familiar with FDA, EU, PMDA regulations, and ICH Guidelines.

Key responsibilities include:
  • Leading the Commercial and Batch Disposition teams to achieve excellence in quality and business objectives.
  • Collaborating with TechOps to support global expansion efforts and new product launches.
  • Ensuring compliance with Marketing Authorization Holder (MAH) and readiness for regulatory inspections.
  • Benchmarking industry standards to continuously improve the Quality Management System (QMS).


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