Administrator, Quality Assurance, Biopharma

Qualifications

• Minimum 3 (preferably 5+) years as IT-system administrator / superuser
• Experience starting up and developing a similar IT system preferred
• Experience in a quality-regulated environment preferred
• Fluent in written & oral English
• University degree a merit.

Qualities

• Strong problem solving and organizational skills
• Focused self-starter with attention to details
• Team-oriented but able to work independently and proactively
• Ability to multi-task in a high-paced work environment


Hansa Medical’s Quality Assurance Department is looking for a creative and structured Administrator to help establish and develop a robust, IT-enhanced quality management system (QMS). The QA Department faces the challenging and exciting task of developing a streamlined, efficient, and adaptable QMS that is tailored for the company’s current needs and is suitable for rapid expansion. If you are interested in actively contributing to process improvement and in building an innovative quality environment, you may be the person we are looking for.

Main Duties

• Establish, administer, develop, and maintain a software system that includes
document management, issue handling, CAPA management, training, etc.
• Administer and maintain an e-signature system
• Administer and maintain electronic records and logs
• General office administration duties as required for the Quality Assurance team
• Create reports with data from IT systems
• Create templates for IT systems

Hansa Medical is a fast-growing biopharmaceutical company developing novel immunomodulatory enzymes for transplantation and acute autoimmune diseases. The lead product, imlifidase, is a proprietary antibody-degrading enzyme currently in late-stage clinical development for kidney transplant patients, with significant potential for further development in other solid organ transplants and in acute autoimmune indications. The company also has a strong pipeline of preclinical projects that may provide a second wave of potential drugs.