Quality Systems Specialist (m/f/d)

Quality Systems Specialist (m/f/d) Date: 15 Jun 2026 Location: Germany Company: terumoeuro At Terumo, we advance lifesaving medical technologies to benefit society. Are you eager to make a difference with us? Here, you’ll grow your expertise while staying true to your personal aspirations. Guided by our Japanese heritage, we act with respect, take ownership, and pursue continuous improvement. If you see yourself in our values, keep reading; this might be the opportunity you're looking for Department Info 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. Job Summary 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. Job Responsibilities 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 Profile Description Education