Temporary Quality Assurance Specialist – Cell Therapy

• 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 SOP's, procedures, policies and 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 (CAPA's).
• Review and approve Change Controls.
• Review Quality documentation for equipment and facility as we build our Cell Therapy Import Hub.
• Use available digital and AI tools to improve and update Quality documentation.
• Host audits forHealth authority inspections on site, including preparation, front room and backroom support, and follow-up.
• Coordinate audit and inspection activities
• Compile, coordinate and draft responses to audit and inspections findings, working with the business to make sure responsesare complete and consistent.
• Own the CAPA's arising from audits and inspections, coordinate them with the responsible teams and follow them through to completion.
• Conduct self-inspections on site and drive the actions that come out of this to closure.

• A bachelor's or master's degree.
• Experience hosting audits and Health authority inspections.
• Experience coordinating audits and inspections, compiling responses to findings, and managing the resulting CAPA's.
• Experience conducting self-inspection.
• 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 and of broader QMS management.
• 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 electronic QMS. Veeva experience is an advantage.
• Professional proficiency in English; Dutch is a plus.

Experience in Cell Therapy is a strong advantage, especially because of the specific requirements around batch disposition and release.

Experience in biologics is also highly relevant.

You must currently live within commuting distance of our Amsterdam site.

Your effort is rewarded

As a Quality Assurance Specialist, you can expect much in return for your dedication. In addition to a competitive salary, you will enjoy:

• A 13th-month salary on top of your monthly pay.
• Access to internal training and development programs.
• 27 vacation days, plus additional leave (such as your birthday, Good Friday, and the period between Christmas and New Year's Eve).
• Flexible and progressive employment benefits, allowing you to tailor them to your needs (e.g., a wellness budget and the choice of a holiday calendar based on different religious beliefs).
• A pension plan.
• This is a 12 month temporary contract position. Payroll and salary administration for this role are handled by an external agency.