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\\xe2\\x84\\xa2 has successfully completed Phase I in burns patients. Clinical Phase II 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

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Head of Quality Assurance (30-50%)

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who can manage the development of next-generation skin grafts and start as of now or per arrangement.

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Your main duties
As Head of Quality Assurance, you are responsible for ensuring and fostering a pro-active, phase appropriate approach to the establishment of a complete and independent Quality Management System
(QMS).

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\\xe2\\x9e\\xa2 Ensure compliance to codes, standards, regulations and QMS requirements, including creation/revision of appropriate SOPs

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\\xe2\\x9e\\xa2 Act as the company Qualified Person (QP/ FvP)

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\\xe2\\x9e\\xa2 Implement metrics and measures to drive assessment and continuous improvement.

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\\xe2\\x9e\\xa2 Management and review of trends and report significant investigation/deviation issues and system deficiencies

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\\xe2\\x9e\\xa2 Manage inspection readiness activities and contribute to regulatory health authority inspections

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\\xe2\\x9e\\xa2 Establishing service standards for end users (i.e., internal department or external customer);

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\\xe2\\x9e\\xa2 Identifying and developing Quality Assurance personnel certification requirements and continuing education/training needs

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\\xe2\\x9e\\xa2 Providing leadership, mentorship, and direction to our Quality Assurance personnel

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Your background

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You hold a minimum M.Sc. in a biological field (e.g., Biology, Pharmacy/ Biotechnology/ Chemistry) or a comparable education with a minimum of 12 years working experience in regulated industry in similar position. Pharmaceutical industry is preferred.

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Desired Skills and Experience

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\\xe2\\x9e\\xa2 Expert knowledge of Process Validation, particularly Swissmedic, EMA, FDA and ICH requirements

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\\xe2\\x9e\\xa2 Experience in developing and monitoring of project QA budgets.
\\xe2\\x9e\\xa2 Experience working within local jurisdictional and regulatory authorities

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\\xe2\\x9e\\xa2 Advanced ability to communicate effectively, both verbal and written, with internal organization departments, suppliers, subcontractors, and regulatory authorities
\\xe2\\x9e\\xa2 Strong coordination and organization skills, with strict emphasis on accuracy and attention to detail
\\xe2\\x9e\\xa2 Exercise sound and balanced judgment in ensuring that written procedures are followed and in evaluating quality systems, processes, procedures, plans and protocols for compliance
\\xe2\\x9e\\xa2 Must have the ability to work within strict deadlines and under pressure while maintaining a professional demeanor
\\xe2\\x9e\\xa2 Proven experience in relevant roles, particularly as Qualified Person in Switzerland
\\xe2\\x9e\\xa2 Thorough knowledge of methodologies of quality assurance and standards
\\xe2\\x9e\\xa2 Excellent understanding of data analysis/statistical methods
\\xe2\\x9e\\xa2 Fluent in English and German, both oral and written. Italian/French is a plus

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Place of work

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Grabenstrasse 11, 8952 Schlieren

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We offer the unique chance to be part of a young and motivated project team with the vision to change the patients\\xe2\\x80\\x99 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:

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\\xe2\\x9e\\xa2 High pace start-up environment

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\\xe2\\x9e\\xa2 Flexible working hours in arrangement with the Direct Supervisor

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\\xe2\\x9e\\xa2 Competitive benefit package

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\\xe2\\x9e\\xa2 A dynamic team

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\\xe2\\x9e\\xa2 5 weeks holidays

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Are you curious to find out more?

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If you are interested in applying for this position, please send your complete application, which should include the following documents in English

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\\xe2\\x9e\\xa2 One-page motivation letter
\\xe2\\x9e\\xa2 Curriculum vitae
\\xe2\\x9e\\xa2 Copies of degrees and references by using the following link:

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Apply Online

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

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HC Solutions AG \\xe2\\x94\\x82 Zollikerstrasse 153 \\xe2\\x94\\x82 8008 Z\\xc3\\xbcrich \\xe2\\x94\\x82 044 915 12 12 \\xe2\\x94\\x82 www.hcsolutions.ch

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Art der Stelle: Teilzeit

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Leistungen:

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• Firmenanl\\xc3\\xa4sse\\n
• Homeoffice\\n

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M\\xc3\\xb6glichkeit zu pendeln/umzuziehen:

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• 8952 Schlieren, ZH: bereit sein zu pendeln oder vor Antritt der Stelle einen Umzug zu planen (W\\xc3\\xbcnschenswert)\\n

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Arbeitsort: Vor Ort