CUTISS AG, a biotech company spin-off of the University of Zurich (UZH), focuses on the development of personalized bioengineered skin graft products for the treatment of skin defects. Its lead product denovoSkin™ has successfully completed Phase I and II in burns patients. Clinical Phase III studies are underway in Europe and Switzerland.
For our expanding Quality Department in Schlieren, Switzerland, we are seeking a highly motivated:
Senior Quality Assurance Specialist 100% (f/m/d)
We are looking for an engaged team player who can work both independently and collaboratively. The ideal candidate will demonstrate strong interpersonal skills as well as clear and professional communication, both verbal and written.
Your main duties:
- Implementing and maintaining the Quality Management System (QMS) and quality compliance for autologous skin substitutes according to Good Manufacturing Practice (GMP) guidelines.
- Performing risk analyses, quality assessments, and product reviews.
- Writing, reviewing, and managing project-specific documentation (Standard Operating Procedures (SOPs), Work Instructions (WIs), and related forms).
- Overseeing incident management and Quality Assurance (QA) compliance Deviations, Corrective and Preventive Actions (CAPAs), Change Controls, and Out of Specification (OOS) investigations.
- Preparing and reviewing production orders, batch records, and material release documentation.
- Participating in internal audits and coordinating supplier qualifications.
- Overseeing raw materials and consumables management (specifications, certificates, and release).
- Supporting inspection readiness and compiling cleanroom certification packages
- Overseeing Good Manufacturing Practices (GMP) training programs.
Your background:
University degree (B.Sc., M.Sc., or Ph.D.) in a biological/scientific field, or a comparable education, with 3+ years (5+ years for a Senior role) of practical experience in Quality Assurance within a GMP-regulated biotech or pharmaceutical environment. Deep expertise in QMS maintenance, deviation handling, CAPA management, and batch record review is a must. Familiarity with cleanroom regulations and Swissmedic/ the European Medicines Agency (EMA)/ the Food and Drug Administration (FDA) guidelines is highly advantageous.
Desired skills and experience:
- Knowledge of Good Manufacturing Practices (GMP) operations, ideally in manufacturing of biologics, is beneficial.
- Fluent in English both oral and written is mandatory, German is a plus
- Attention to detail with excellent organizational and record keeping.
- Ability to work independently and efficiently.
- Excellent interpersonal skills and team-oriented attitude.
We offer the unique chance to be part of a young and motivated team with the vision to change the patients’ quality of life. This interesting and challenging role will give you the opportunity to further develop your working skills in a late-stage biotech start-up environment. In summary you can expect:
- A high-paced start-up environment
- Competitive benefit package
- A young and dynamic team
- 26 days of holidays
- One day off for your birthday
Special remarks:
This position requires occasional weekend duties.
Starting Date: 1st August 2026
Are you curious to find out more?
If you are interested in applying for this position, please send your complete application, which should include the following documents in English
- One-page motivation letter
- Curriculum vitae
- Copies of degrees and references
If you are interested in applying for this position, please use the "Apply" button above.
For this position, only direct applications and Swiss work permit holders will be considered.
