Quality Assurance Manager

Full Time
Student (College)

As a global Research Organization to the biopharmaceutical industry, CellCarta (formerly Caprion – HistoGeneX) provides access to a broad offering of biomarker platforms and services. We partner with our clients to address the most complex scientific testing needs, delivering customized biomarker testing solutions to further the limitless potential of precision medicine.

We offer our services on a global scale through our laboratories in USA, Canada, Belgium, China and Australia. Combining expertise in histopathology, immune monitoring, proteomics, genomics and sample logistics, we support pharmaceutical and biotechnology companies in the research and development of innovative new medicines for the treatment of cancer and immune diseases. Working under stringent quality and regulatory requirements, we strive to make a difference in the future treatment options offered to patients.

CellCarta leverages its strong expertise in cancer to support the entire spectrum of biomarker services including biomarker discovery in the research phase, tumor profiling and biomarker monitoring in clinical studies and companion diagnostics registration studies, patient diagnostics and development of new techniques and tests for tumor analysis and prediction of treatment response. The company bridges the gap between research, clinical studies and diagnostics.

We are currently recruiting a Quality Assurance Manager

Department: Quality Assurance

Based in

Wilrijk, Antwerp (Belgium)


The QA Manager works as member of the Quality Assurance team, ensuring that all activities are performed in accordance with GCP, GCLP, CAP/CLIA and ISO13485.

Major Responsibilities

• Assist in defining quality procedures in conjunction with the operational teams (SOPs, forms, work instructions, policies)

• Assist in administrative duties related to the QA section

• Perform internal audits

• Participate in sponsor audits and regulatory inspections (preparation, hosting and follow-up actions)

• Participate in review of non-conformities, deviations and complaints and support to related investigations

• Participate to the CAPA review process

• Work with relevant departments to ensure timely closure of quality action plans

• Actively contribute to continuous improvement and quality awareness initiatives

• Contribute to the implementation of new quality standards (ISO13485) 

• Ensure registration of QA related training

• Contribute to the preparation of management reviews

• Assist in the follow-up of KPI’s

• Contribute actively in the risk management activities of the company


• Bachelor or Master Degree in life sciences with preferably 3 years of experience in a quality assurance role in a laboratory or an IVD manufacturing environment

• Advanced knowledge, orally and in writing of English, knowledge of Dutch and French is a plus

• Excellent organizational skills

• Dynamic personality, a true team player with good interpersonal skills

• Analytical thinker with a process-oriented mindset

• Ability to work independently

• Good documentation skills (accurate, attention to details)

• Experience related to quality and regulatory aspects of in vitro diagnostic devices (ISO13485, IVDD, IVDR and/or FDA IDE and PMA regulations) is an advantage

• Willingness to travel

What can we offer

• A dynamic and rapidly changing global environment allowing personal growth

• A company that is fit for the future

• A competitive salary and benefits

• A great team you can work with


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