Quality Assurance Specialist – Cell Therapy

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About the role

Bring your Quality experience to Cell Therapy. Join our growing Cell Therapy team in Amsterdam in a hands-on Quality role. You will work with batch documentation, Quality systems and QPs, while helping us improve our processes as our operations grow. Quality Assurance Specialist – Cell Therapy Amsterdam Full-time or 4 days per week Hybrid, 3 days on-site The role As a Quality Assurance Specialist, you combine hands-on Quality Assurance with Global Quality Management System (QMS) activities. You work closely with our Qualified Persons (QPs) and Quality colleagues to make sure documentation is complete and correct, Quality actions are followed up and our operations remain compliant. You also help improve Quality processes and ways of working as our site develops. Our Cell Therapy operation in Amsterdam is growing, and we are building our Cell Therapy Import Hub. To support this growth, we are expanding our Quality team. What will you do? Around 70% of your role is focused on daily Quality operations, including batch documentation review, quality records review, compiling the Batch disposition packet and working with our QPs. Around 10% is focused on improving processes and ways of working, with the remaining time spent on Global QMS activities, training, meetings and follow-up. • Review batch documentation for batch disposition/QP certification. • Identify missing or incomplete documentation, coordinate actions with the right teams and follow them through to completion. • Write, review and update SOPs, procedures, policies and other Quality documents. • Review Quality and manufacturing records and identify gaps, risks, deviations and required follow-up. • Investigate Quality deviations and coordinate corrective and preventive actions (CAPAs). • Review and approve Change Controls. • Facilitate & Coordinate Change Control Review Board Meetings. • Compile, evaluate and present Quality Systems data and metrics for Quality Management Review Meetings. • Train colleagues on GMP, QMS procedures and other core Quality processes. • Prepare for audits and inspections and participate in audit and inspection activities. • Review Quality documentation for equipment and facility as we build our Cell Therapy Import Hub. • Identify Quality or compliance concerns, take action and escalate when needed. • Use available digital and AI tools to improve and update Quality documentation. Who are you? You enjoy detailed, documentation-driven work. You like reviewing documents, checking details and making sure Quality records are complete, correct and compliant. You take ownership. When something needs attention, you follow it up, involve the right people and make sure it gets resolved. You will work in a small Quality team on a site that is still developing. Processes and priorities can change as we build the organisation. You are comfortable with this, stay calm under pressure and look for practical solutions. You are self-motivated, flexible and curious. You can manage several priorities at the same time and actively look for ways to improve how things are done. Essential skills and experience • A bachelor’s or master’s degree. • At least 2 years of hands-on Quality Assurance experience in a GMP manufacturing environment. • At least 2 years of experience writing and reviewing Quality documentation, including SOPs and procedures. • At least 2 years of experience with deviations, CAPAs and change controls. • Experience reviewing batch documentation and Quality records. • Good knowledge of GMP and Quality Systems. • Knowledge of and ability to apply GMP in conformance to US, EU and ROW standards. • The ability to identify gaps and risks in Quality records and determine what follow-up is needed. • Experience working with an electr

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