QA Specialist — ATMP Cell & Gene Therapies (GMP)

Prinses Máxima Centrum; Utrecht; On-site; EUR 39,000 - 55,000; Full time

Benefits offered by this job

8.33% holiday allowance

8.33% end-of-year bonus

Job summary

Princess Máxima Center in Utrecht is seeking a QA Specialist to lead and maintain a GMP-compliant quality system within the Cell and Gene Unit, advancing ATMP manufacturing and related quality activities.

You will collaborate with production, regulatory, and clinical QA teams to ensure inspections pass and continuous improvement is driven, with a competitive salary and a 36-hour work week.

Qualifications

• BSc or MSc in Biomedical or Life Sciences or related field.
• Proven QA experience in ATMP manufacturing.
• Knowledge of EU regulatory framework, WVKL licensing, and JACIE standards.
• Strong English communication; Dutch is a plus.

Responsibilities

• Establish and maintain a GMP-compliant quality system within the CGU.
• Guide production and control activities to ensure GMP compliance.
• Maintain TE licence and contribute to quality aspects.
• Collaborate with clinical QA teams to align quality activities with patient care.
• Manage change controls, documentation, deviations, CAPA, and risk assessments.
• Support regulatory and accreditation compliance and drive improvements.
• Oversee equipment qualification and validation activities.
• Participate in inspections and audits of suppliers and service providers.
• Analyse quality data and present trends and corrective actions.
• Ensure training system is compliant and qualified personnel perform activities.
• Contribute to strategies to enhance quality practices.

Skills

Quality Assurance

ATMP manufacturing

EU regulatory knowledge

JACIE standards knowledge

English communication

Education

BSc or MSc in Biomedical or Life Sciences

Job description

Princess Máxima Center in Utrecht is seeking a QA Specialist to lead and maintain a GMP-compliant quality system within the Cell and Gene Unit, advancing ATMP manufacturing and related quality activities.

You will collaborate with production, regulatory, and clinical QA teams to ensure inspections pass and continuous improvement is driven, with a competitive salary and a 36-hour work week.