Quality Systems Specialist (m/f/d)

Terumo Pharmaceutical Services (TPSG) in Leverkusen is part of Terumo’s global Pharmaceutical Solutions division, supporting pharmaceutical and biotechnology companies with high-quality contract development and manufacturing services.

Within TPSG, the Quality department plays a critical role in ensuring compliance with GMP requirements, maintaining robust quality systems, and safeguarding product quality for our partners and patients. The team collaborates closely with internal departments, suppliers, and external stakeholders to drive continuous improvement and operational excellence.

As Quality Systems Specialist, you are responsible for coordinating and executing key quality system activities to ensure compliance with internal policies and applicable regulatory requirements.

You will play a central role in supplier qualification, audit readiness, KPI monitoring, and the management of quality processes such as deviations, CAPAs, and change controls. Through your work, you contribute directly to maintaining high-quality standards and supporting TPSG’s compliance framework.

Your main responsibilities include:

• Execute supplier qualification and requalification activities for service providers, GMP materials, and computerized systems (e.g. audits, questionnaires, certificate management)


• Manage and execute quality processes, including:
  
  
  
  • Change control
  
  
  • Deviation management
  
  
  • CAPA management
  
  
  
  


• Collect, analyse, and report Key Performance Indicators (KPIs) to support quality monitoring and continuous improvement


• Support and participate in internal audits, client audits, and regulatory inspections


• Collect and prepare data for Management Review and Annual Product Review (APR)


• Develop, maintain, and continuously improve Standard Operating Procedures (SOPs) related to the Quality Management System


• Support additional quality activities such as training coordination and documentation management

At Terumo, we are committed to Advancing Healthcare with Heart. We offer:

• A meaningful role in an international healthcare company with a strong purpose


• A collaborative and quality-driven work environment


• Opportunities for professional development and continuous learning


• A culture of respect, teamwork, and continuous improvement


• Competitive compensation and benefits package