Site Head QA in Antwerp

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 Site Head QA in Antwerp in order to support further expansion of the company.

The Site Head QA leads the Quality Assurance team of the Antwerp site, ensuring that all activities are performed in accordance with GCP, GCLP, CAP/CLIA and ISO standards.

You will report to the Section Head Quality Assurance.

Your Responsibilities

  • Implementation and maintenance of a system for management of controlled documents
  • Coordinate the implementation of new quality standards (ISO13485)
  • Implementation and execution of the internal and vendor audit program
  • Direct and coach the QA team in Antwerp.
  • Lead external audits related to the site (sponsor audits, regulatory audits and inspections)
  • Setup and analyze quality metrics in order to identify opportunities for continuous improvement
  • Report and escalate quality issues to management
  • Supervise the follow-up of quality events such as incoming complaints, nonconformities, outgoing complaints and sponsor/accreditation/regulatory inspection audit findings
  • Provide guidance, interpretation and information on the applicable quality standards when requested
  • Lead the site management review
  • Ensure QA related training is provided to HistoGeneX employees
  • Lead quality improvement initiatives across functions
  • Lead change management initiatives to improve business performance

 

Profile requirements

  • Master Degree in Science (preferably Biology, Biomedical Sciences, Bioengineering, Pharmaceutical sciences, Biochemistry) with a minimum of 5 years of experience in a quality assurance role in a medical laboratory or IVD manufacturing environment.
  • Strong experience related to quality and regulatory aspects of in vitro diagnostic devices (ISO13485, IVDD, IVDR and/or FDA IDE and PMA regulations) is required.
  • Advanced knowledge, orally and in writing of English, knowledge of Dutch and French is a plus
  • Excellent organizational skills
  • Dynamic personality, a true team leader with good interpersonal skills
  • Analytical thinker with a process-oriented mindset
  • Good documentation skills (accurate, attention to details)
  • 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.