CUTISS AG is a biotech company spin-off of the University of Zurich (UZH) and focuses on the development of personalized bioengineered skin graft products for the treatment of skin defects. Clinical Phase III studies are underway in Europe and Switzerland.
CUTISS AG aims at designing an intelligent, automated platform to accelerate the manufacturing of its bioengineered skin product. Therefore, we are seeking a highly dedicated Quality Control Manager who can start immediately or as agreed.
The Quality Control Manager is responsible for leading all QC activities related to the testing, monitoring, and release of denovoSkin consumables, intermediates, and final product. This role drives analytical method validation and the assessment of innovative technologies, ensuring compliance with regulatory standards while supporting company objectives and long-term goals.
Your Key Responsibilities:
Ensure QC activities (monitoring, testing, release) are performed on time, in compliance with internal procedures, GMP, and regulatory guidelines.
Maintain site readiness for regulatory inspections; represent QC during audits and support preparation activities.
Lead, supervise, and continuously improve the QC unit for ATMP manufacturing across clinical and commercial phases.
Converse facility-related QC activities, including equipment qualification, maintenance, validation, and certification, in line with ATMP regulatory requirements.
Contribute to regulatory submissions (IMPD/IND/BLA). Lead investigations and root cause analyses of quality events linked to QC activities. Responsible for analytical method validations and method investigations.
Provide leadership, mentorship, and guidance to a QC team of ~10 members.
Your Background:
The ideal candidate holds a B.Sc. in a biological discipline (M.Sc. preferred), such as biology, tissue engineering, biotechnology, or biomedicine, or an equivalent qualification. A minimum of 5 years of experience in a regulated industry (pharmaceutical industry preferred) is required, with proven team management experience strongly preferred.
Desired Skills and Experience:
Proven experience as a Quality Control manager or relevant role
Experience in cleanroom shutdown planning and execution
Experience in maintaining cleanrooms and equipment
Excellent knowledge of Process Validation, particularly EU, FDA and ICH requirements
Ability to develop and manage non-conformance, deficiencies, including root cause analysis
Experience working within local jurisdictional and regulatory authorities
Exercise sound and balanced judgment in ensuring that written procedures are followed and in evaluating quality systems, processes, procedures, plans and protocols for compliance
Good knowledge of safety programs
Supervision of safe storage and verification of all project related documentation, both paper documents and electronic files
Excellent numerical skills and understanding of data analysis/statistical methods
Excellent organizational and leadership abilities
Great sense of quality and responsibility, high level of accuracy
Communicative, team-oriented
Reliable and Trustworthy
Solid IT user skills e.g. Microsoft Office and databases
Proficient in German and English (any other languages, particularly Italian, are a plus)
Place of work
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 role 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:
Fast pace start-up environment
A young and dynamic team
26 days of vacations
One day off for your birthday
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
Copies of degrees and references
For further information regarding the role and the recruitment process, please contact CUTISS AG at info@cutiss.swiss.
Seniority level Mid-Senior level
Employment type Full-time
Job function Quality Assurance
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