Senior Specialist Quality Systems

Our client is a leading biopharmaceutical company focused on developing innovative treatments for cancer. The organisation operates a GMP-regulated manufacturing site in the Netherlands and works within a highly regulated quality environment. You will join a Quality Systems team that works across the site and collaborates with multiple departments to maintain and continuously improve the quality management system. We are looking for a Senior Specialist I – Quality Systems for a 6-month assignment.

In this role, you will support the management and continuous improvement of key Quality Systems, with a strong focus on Change Control, Deviations, CAPA, Material Review and quality metrics. You will work closely with different departments across the site, provide training on Quality Systems and support quality governance and compliance activities. Responsibilities include managing and maintaining Change Control, Deviation and CAPA systems; supporting and acting as backup chair for relevant quality review boards; managing the Material Review Board process; delivering and coordinating Quality Systems training; monitoring site compliance with quality procedures and requirements; reviewing and approving changes to systems and procedures; reviewing and approving deviations and CAPAs; tracking and reporting quality metrics and management information; supporting Quality Management Reviews, audits and regulatory inspections; ensuring proper maintenance of the Quality Management System and cGMP documentation; identifying quality risks and opportunities for process improvement; working with cross-functional and cross-site stakeholders; and supporting the team with day-to-day Quality Systems activities.

Requirements include a Bachelor’s or Master’s degree in a technical discipline such as Chemistry, Microbiology, Engineering or similar; minimum 5 years of Quality Assurance experience in a GMP environment; strong experience with Change Control, Deviations and CAPA; working knowledge of EU GMP and ICH Q10; experience with Quality Systems and quality governance; strong knowledge of aseptic manufacturing processes; experience working with quality metrics and review boards; strong written and verbal communication skills; ability to work independently with scientific and technical personnel; flexibility, pragmatism and strong team player.

Experience with ATMPs / cell and gene therapy is an advantage, as is experience with Power BI, Power Automate, Smartsheet or similar tools.