Home QA Manager GCP

Kiadis Pharma is focused on cell-based immunotherapy products, as an adjunctive to a haploidentical hematopoietic stem cell transplantation (HSCT), for the treatment of blood cancers and inherited blood disorders. The Company’s product candidates have the potential to make allogeneic HSCT safer and more effective for patients.

Based on the positive results from the single dose Phase II trial with lead product ATIR101™ in patients with blood cancer, the Company submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in April 2017, for approval of ATIR101™ across the European Union as an adjunctive treatment in HSCT for malignant disease. In addition, Kiadis Pharma has received regulatory approval in various countries to start dosing patients in a Phase III trial with ATIR101™ that will be performed across Europe and North America. ATIR101™ has been granted Orphan Drug Designations both in the US and Europe.

The Company’s second product candidate, ATIR201™, will address beta thalassemia, an inherited blood disorder.

Kiadis Pharma was granted an Advanced Therapy Medicinal Product (ATMP) certificate for manufacturing quality and non-clinical data by the EMA.

The Company’s shares are listed on Euronext Amsterdam and Euronext Brussels.

Due to the further growth of the company, Kiadis is looking for a QA Manager.

In this role, you will:

  • Be responsible for correct use of QA systems, SOP’s and Procedures with focus on GCP operations
  • Manages QA related aspects of clinical trials
  • Audit clinical sites from a QA compliance perspective
  • Write, review and approve applicable controlled documentation, e.g. records, [audit] reports, protocols and other GCP documentation
  • Develop training material and train personnel

The ideal candidate

Holds minimal a MSc in a Biotechnology or equivalent field. You have at least 12 years of experience in pharmaceutical industry with a minimum of 8 years in a similar QA-role. Preferably you have experience with cell-based ATMP’s. To be successful, you are a team player who will bring result-orientedness, integrity, tenacity and communication skills.

We offer

A challenging position in an innovative, fast growing, biotechnology company. Working in a fast-paced dynamic environment brings the opportunity to make your own mark within the organization.

You will be rewarded a competitive remuneration package, the opportunity for personal development and to contribute to make a huge difference for patients.

For further information, please contact Jeroen Elderhorst, HR Manager, by phone at +31 (0)20 3140 250. You can e-mail your motivation letter and resume to recruitment@kiadis.com.