Quality Assurance (QA) Specialist – Cell and Gene Unit

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

Quality Assurance (QA) Specialist – Cell and Gene Unit

3.463 - 4.914

Are you an experienced Quality Assurance (QA) Specialist looking to make a meaningful impact? At the Princess Máxima Center for pediatric oncology, you will work at the forefront of innovation, helping to develop advanced cell and gene therapies that have the potential to transform lives. To further shape our new Cell and Gene Therapy Unit (CGU), we are seeking a skilled and motivated QA Specialist with a strong background in Advanced Therapy Medicinal Products (ATMPs). This is your opportunity to contribute to cutting-edge cancer treatments in a dynamic and pioneering environment.

About the Cell and Gene Unit

The Princess Máxima Center is building a state-of-the-art facility where the primary focus will be the manufacturing of ATMPs. Alongside production, the CGU will play a vital role in translational research to advance and refine innovative therapies. Would you like to know what it’s like to work in our CGU? Rachel shares more about her work in the Cell and Gene Therapy Unit in this article .

The Princess Máxima Center for Pediatric Oncology is an integrated hospital and research institute, which integrates healthcare, research and education on paediatric cancer, in a single location in Utrecht. Our institute aims to provide the highest level of care for all children with cancer, with optimal quality of life. The centre brings together the best possible care and scientific research, creating a unique interdisciplinary institute for paediatric oncology in Europe.

Your Key Responsibilities

As a QA Specialist, you will take the lead in establishing and maintaining a GMP-compliant quality system within the CGU, ensuring all activities meet regulatory and accreditation standards. Responsibilities include:

• Implementing, managing, and monitoring a GMP-based quality system.
• Guiding production and control activities to ensure full compliance with GMP standards.
• In addition, the CGU will also maintain a tissue establishment (TE) licence and the post holder will be expected to contribute to all quality related aspects.
• The host holder will also have close integration and collaboration with the clinical QA teams, offering a unique opportunity to be at the forefront of quality activities that directly impact patient care.
• Implementing and managing change controls, documentation, deviations, CAPA systems and risk assessments.
• Supporting regulatory and accreditation compliance and driving continuous improvement initiatives.
• Quality oversight and approval of equipment qualification and validation activities
• Participating in regulatory and accreditation inspections.
• Conducting internal and external audits, including of suppliers and service providers.
• Analysing and presenting quality management data, including trends and corrective actions.
• Ensuring a compliant, documented, and effective training system so that only qualified personnel perform GMP and TE activities.
• Contributing to strategies that enhance quality practices and systems.

Your Profile

You are analytical, resourceful, and able to manage a varied workload. You excel in building strong relationships within a multidisciplinary team and are motivated by the challenge of driving innovation in a high-stakes environment.

Additionally, you bring:

• A BSc or MSc degree in Biomedical or Life Sciences, or a related field.
• Proven experience in Quality Assurance, ideally within an ATMP manufacturing facility.
• In-depth knowledge of the EU regulatory framework, WVKL licensing, and JACIE standards.
• Strong verbal and written communication skills in English; proficiency in Dutch is a valuable asset.

Working at the Princess Máxima Center

We offer a full-time position (based on 36 hours a week) in a very stimulating and interactive environment. The contract will be initially for one year, with the possibility to extend upon satisfaction. Your gross monthly salary (FWG 50-55) will be based on your experience and background and will include 8,33% holiday allowance and 8,33 % end-of-year bonus. The Princess Máxima Center operates according to the collective labor agreement ‘CAO ziekenhuizen’.