QS Associate QRM & Excellence

The QS Associate QRM & Excellence is responsible for supporting the continuous improvement within the quality systems department of CAR-T Belgium (Ghent and Beerse). This includes the execution of lean/six sigma projects and maintaining & improving the quality risk management (QRM) framework.

Your responsibilities:

• Lead or support lean projects aligned with QS objectives and site strategy, including process mapping and waste identification.
• Collect and analyze process data to establish baselines, build dashboards, and track performance trends.
• Implement process improvements such as standard work, visual management, error-proofing, and 5S.
• Maintain and enhance the integrated risk management framework, ensuring compliance and proper documentation.
• Collaborate cross-functionally to identify, assess, and mitigate risks; monitor and report progress on risk activities.
• Act as delegate for Site Risk Representative and back-up for local risk process owner; support audits and inspections.
• Monitor SHE compliance, promote prevention awareness, report unsafe conditions, and contribute to safety solutions.

Requirements and qualifications:

• Master’s degree in a scientific/technical field and 2–3 years of experience in a GMP environment.
• Solid knowledge of pharmaceutical regulations and GMP standards.
• Familiarity with core QS processes (CAPA, Change Control, Deviations, Document Management).
• Exposure to Lean/Six Sigma methodologies and proficiency in data analysis tools (Excel, Minitab).
• Understanding of risk management standards (ICH Q9, ISO 31000) and experience with Health Authority inspections.
• Strong analytical, decision-making, and organizational skills; able to manage multiple tasks independently.
• Excellent communication skills for effective interaction with internal and external stakeholders.

Hybrid Wor