Quality Assurance Associate (f/m/d, 100%)

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
denovoSkinTM has successfully completed a Phase I clinical trial for the treatment of burns and
reconstructive surgeries. Clinical Phase II studies are underway in Europe and Switzerland.

For our Quality Assurance department in Schlieren, Switzerland, we are currently seeking an
experienced

The qualified candidate is a highly motivated, interactive individual that possesses the ability to work
individually and collectively. He/she will demonstrate clear and professional verbal, written
communication and reporting.

Your main duties

• Ensuring the proactive, phase-appropriate management of a complete and independent Quality
  Management System (QMS), as well as supporting and preparing for QA compliance readiness
  during inspections and audits
• Ensuring compliance to codes, standards, regulations, and QMS requirements, including
  creation/revision of appropriate SOPs
• Managing, preparing and maintaining key QA compliance systems (Deviations, CAPAs, Change
  Control, Risk analysis, Audits)
• Implementing and executing the activities related to the supplier management process as
  outlined in the SOPs (including supplier audits)
• Maintaining QA activities in compliance with Swissmedic, EU, and FDA (if applicable)
  regulations across therapeutic areas
• Participating in the collaboration and negotiations of Quality Agreements with third parties and
  material suppliers
• Training matrix management
• Preparation, reconciliation and archival of controlled copies for PROD and QC departments

Your background
You hold a M.Sc./PhD in a natural science field field (e.g., pharmacy, biology, tissue engineering,
biotechnologies, and biomedicine) or a comparable education. Knowledge of medical device regulation
is a plus. You gained 1+ years working experience in QA related role in pharmaceutical companies in a
wide spectrum of QA activities.

Desired Skills and Experience

• Must have work permit in Switzerland

• At least 1 years of experience in QA related role in biopharmaceutical companies (ideally
  ATMPs) in wide spectrum of QA activities, including active inspection experience Fluent in
  English both oral and written, German is a plus

• Attention to detail with excellent organizational and record keeping

• Great sense of quality and responsibility

• High level of accuracy and organizational skills

• Demonstrate ability to work independently and efficient

• Self-reliant in determining priorities

• Excellent interpersonal skills and team-oriented attitude

• Proficient in English, German is nice to have and any other languages are a considered a plus

Place of work
Grabenstrasse 11, 8952 Schlieren

We offer the unique chance to be part of a young and motivated project team with the vision to change
the patients’ quality of life. This interesting and challenging job will give you the opportunity to further
develop your working skills in a biotech start-up environment and to get in touch with international
partners and clinical trial centers. In summary you can expect:

• A high pace start-up environment
• Flexible working hours in arrangement with the team leader
• Competitive benefit package
• A young and dynamic team
• 26 days of holidays/year

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

by using the following link:

https://apply.refline.ch/517628/0787/index.html

For further information regarding the recruiting process, please contact our HR partner HC Solutions,
Annika Danielsson or Alessia Cesari.

HC Solutions AG ¦ Zollikerstrasse 153 ¦ 8008 Zürich ¦ 044 915 12 12 ¦ www.hcsolutions.ch