Kiadis Pharma is a biopharmaceutical company based in Amsterdam, The Netherlands. We focus on the treatment of blood cancers and inherited blood disorders aiming to make bone marrow transplantations, a procedure that is often the last hope for patients, safer and more effective. We have a passionate team that is dedicated to make a huge difference for patients.
Are you a Quality Specialist with a robust background in Clinical research and with great technical GCP knowledge? If you are up to the challenge and would like to be part of our QA team, we are currently looking for a
CLINICAL QA MANAGER
with a specialism in GCP
- 40 hours
- Location: Amsterdam
The QA Manager will support the existing Head of QA in the day-to-day activities. You will be responsible for ensuring that clinical processes are conducted in accordance with Guidelines, Directives, Regulations and applicable inter[national] laws. To be successful, we require you to be a team player who has a robust background in clinical trial development, is focused, flexible and have good communication skills. Since we work with sites all over the world, you will also get the chance to travel up to 30% within Europe & North America.
- Perform Audits in internal, domestic and international clinical investigational sites and vendors to ensure compliance with applicable regulatory requirements.
- Manage and Provide guidance on GCP related aspects of clinical trials where appropriate.
- Assist with the preparation, coordination and management of Regulatory Authority Inspections.
- Generation and execution of QMS related procedures with focus on GCP procedures.
- Review and approve applicable controlled documentation, e.g. SOPs and other GCP documentation.
- Develop training material and train personnel on GCP related topics.
The ideal candidate would have:
- HBO/University degree in biomedical and/or life sciences / certification in a related allied health profession, preferably with a background in Hematology and/or Oncology.
- 5+ years experience in clinical trials working in a GCP regulated environment specializing in international biopharmaceutical [ATMPs] clinical trials phase I through III, with preferably 3- 5 years experience as an auditor
- An understanding of pharmaceutical manufacturing and GMP requirements
- Fluency in English, both in oral and written communication, with a preference for Dutch proficiency
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. If you’re interested in the position please apply through the application button or contact Recruitment@kiadis.com with any questions.
If you’re interested in the position
Please apply through the application button via this link.
Acquisition will not be appreciated. Any unsolicited CV’s received by agencies will be treated as direct Kiadis applicants – without any fee obligations.
Keywords: Vacancy, HBO, WO, Biomedisch, Life sciences, Laboratoriumonderzoek, Laboratoriumtechniek, Amsterdam, Noord-Holland.