Dynamic biotech company / very promising pipeline / challenging role within a dedicated QA-team
- Dynamic, direct and international working environment within a result driven organisation
- Contributing to a company with a unique position with high expectations for the future
- Good salary and a competitive remuneration package
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 allergenic 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 ATIR 101™ 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 and 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 Senior QA Officer.
Within this growing company, as a Senior QA Officer you will contribute to establishing and maintaining a strong and committed QA department that will transfer the QA culture into all departments of Kiadis (e.g. by developing training material and by training personnel). From your broad experience with QA and biotech, you will be responsible for correct use of QA systems, SOP’s and Procedures within Kiadis Pharma. You will review master documents and batch documentation, perform internal and/or external audits and write, review and approve applicable controlled documentation (e.g. batch records, audit reports, protocols and other cGxP QMS documentation). Besides this you will perform initiation, review and assessment of deviations, change control requests, CAPA’s, OOS and other QMS input.
In short, you will be responsible for all the core QA related tasks within a dynamic, flexible and successful biotech company that is in a transition from Phase II to Phase III. You have to understand the regulations and be able to communicate that to all levels in the organisation. You will work together with a QP, a QA Manager and a Senior Director QA. You report to the latter.
- B.Sc. in biotechnology, chemistry or equivalent field
- Minimal 6 years of experience within the pharmaceutical/biotech industry with minimal 3 years experience in a similar QA-role
- Good understanding and knowledge of cGMP / ICH guidelines for both US and USA
- Experience with and knowledge of QMS, CAPA’s, deviations, SOP’s and batch record reviews is a must
- Experience with auditing is an advantage
- Confident, flexible, open, honest and approachable
- Excellent written and verbal communication in English. Knowledge of the German language is an advantage
Interested? Please send your resume and motivational letter by Email, with reference to WL/17-143-DD: email@example.com.
For further information, please call Mrs. Hoedjes at number +31 (0)33 472 80 87.
An individual assessment may be part of the selection procedure.
Our client has chosen Derks & Derks B.V. as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.