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QA Manager

HistoGeneX is a fast growing company specialized in cancer research and tissue characterization. We offer our services on a global scale through our laboratories in Europe (Antwerp, Belgium), the USA (Chicago) and China (Jining).

We support pharmaceutical and biotechnology companies in the research and development of innovative new medicines for cancer treatment.

HistoGeneX is currently recruiting a motivated QA manager in Antwerp in order to support further expansion of the company.

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 ISO15189.

Your 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

Profile requirements

  • 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

We offer an exciting and challenging position in a multinational environment where customer focus and innovation are key business values.

Apply today and send your CV to This email address is being protected from spambots. You need JavaScript enabled to view it.