ATMP QA Specialist: GMP Lead in Cell & Gene Therapy

Prinses Máxima Centrum voor kinderoncologie; Utrecht; On-site; EUR 46,872 - 60,264; Full time

Job summary

The Prinses Máxima Centrum voor kinderoncologie in Utrecht is seeking an experienced QA Specialist to lead GMP-compliant quality systems within the Cell and Gene Therapy Unit (CGU). You will ensure regulatory alignment for ATMP manufacturing, collaborate with clinical QA teams, and contribute to continuous improvement and training, with a one-year contract and a competitive salary based on FWG 50-55.

Strong analytical skills, regulatory knowledge, and language proficiency in English (Dutch a

Qualifications

• Must have a BSc or MSc in Biomedical or Life Sciences.
• Proven experience in Quality Assurance, ideally in ATMP manufacturing.
• Knowledge of EU regulatory framework, WVKL licensing, and JACIE standards.

Responsibilities

• Establishing and maintaining a GMP-compliant quality system within the CGU.
• Guiding production and control activities to ensure GMP compliance.
• Maintaining TE licence quality activities and collaborating with clinical QA teams.
• Supporting regulatory inspections and audits of suppliers and services.
• Managing change controls, deviations, CAPA systems and risk assessments.
• Analysing quality data and contributing to continuous improvement initiatives.

Skills

Analytical thinking

Cross-functional collaboration

Regulatory awareness

Education

BSc or MSc in Biomedical or Life Sciences

Job description

The Prinses Máxima Centrum voor kinderoncologie in Utrecht is seeking an experienced QA Specialist to lead GMP-compliant quality systems within the Cell and Gene Therapy Unit (CGU). You will ensure regulatory alignment for ATMP manufacturing, collaborate with clinical QA teams, and contribute to continuous improvement and training, with a one-year contract and a competitive salary based on FWG 50-55.

Strong analytical skills, regulatory knowledge, and language proficiency in English (Dutch a