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Operational Quality Manager

SGS Group Belgium in EDEGEM
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Online sinds 7 feb. 2025 - gewijzigd sinds 21 feb. 2025

As Operational Quality Manager (OQM) you are welcomed in a smaller, amiable, and enthusiastic
QA team where you will have day-to-day interaction with other QA experts in the field, such as other OQMs, Quality Compliance Managers, Auditors, …

As OQM, you will be an indispensable partner of the operational teams - specifically at our Clinical Pharmacology Unit (CPU) in Edegem - in the management of their part of the quality system.As such, you will gain insight into the different investigator site processes applicable for the conduct of clinical trials for pharma and biotech companies from start to finish.

Your responsibilities:

Your main responsibilities are the following:

  • Collaborate with the assigned operational teams at CPU to improve quality and maintain high quality standards throughout the organization by:
    • Developing and maintaining operational quality (SOPs, WIs, CDs, and manuals and various guidance documents) and personnel documents
    • Leading the non-conformance management process by guiding the teams through the risk assessment of non-conformances, Root Cause Analyses and formulation of CAPA Plans or corrections
    • Supporting the teams by providing additional explanation on topics relating to quality documents/process improvements, development of trainings (e.Learnings, classroom trainings) together with the QA training department
    • Proposing changes to operational quality documents and associated training to improve the quality system
    • Initiating process improvements / efficiencies where needed
    • Supporting the teams in performing their daily work in a consistent and efficient way, by the creation of operational checklists, guidance documents, etc.
  • As assigned, assist in the further development of the new SGS CR electronic Quality Management System.
  • In general, participate in / facilitate cross-functional discussions and working groups related to any aspect of quality at the CPU, to create or optimize cross-functional procedures, or to look for efficiencies in processes, systems, and collaboration.