Quality Assurance (QA) Specialist - Cell and Gene Unit

pbAre 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. /b /pbrLees nu meer over de dagelijkse taken, algemene verantwoordelijkheden en vereiste ervaring voor deze functie door naar beneden te scrollen.brAbout The Cell And Gene UnitpThe 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. /pThe Princess Máxima CenterpThe 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. /ppYour Key Responsibilities /pResponsibilitiespAs 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: /pulliImplementing, managing, and monitoring a GMP-based quality system. /liliGuiding production and control activities to ensure full compliance with GMP standards. /liliIn 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. /liliThe 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. /liliImplementing and managing change controls, documentation, deviations, CAPA systems and risk assessments. /liliSupporting regulatory and accreditation compliance and driving continuous improvement initiatives. /liliQuality oversight and approval of equipment qualification and validation activities /liliParticipating in regulatory and accreditation inspections. /liliConducting internal and external audits, including of suppliers and service providers. /liliAnalysing and presenting quality management data, including trends and corrective actions. /liliEnsuring a compliant, documented, and effective training system so that only qualified personnel perform GMP and TE activities. /liliContributing to strategies that enhance quality practices and systems. /li /ulpYour Profile /pYour ProfilepYou 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. /pAdditionally, You BringulliA BSc or MSc degree in Biomedical or Life Sciences, or a related field. /liliProven experience in Quality Assurance, ideally within an ATMP manufacturing facility. /liliIn-depth knowledge of the EU regulatory framework, WVKL licensing, and JACIE standards. /liliStrong verbal and written communication skills in English; proficiency in Dutch is a valuable asset. /li /ulWorking at the Princess Máxima CenterpWe 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. xgiwjmb The Princess Máxima Center operates according to the collective labor agreement ‘CAO ziekenhuizen’. /pbr