Quality Assurance Lead (f/m/d) (60-100%)Join to apply for the Quality Assurance Lead (f/m/d) (60-100%) role at CUTISS AGQuality Assurance Lead (f/m/d) (60-100%)Join to apply for the Quality Assurance Lead (f/m/d) (60-100%) role at CUTISS AGGet AI-powered advice on this job and more exclusive features.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 in burns patients. 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 dedicatedQuality Assurance Lead (f/m/d) (60-100%)who can manage the development of next-generation skin grafts and start immediately or as agreed.As the leader of the Quality Assurance Department, 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).Your Key Responsibilities:Provide expert guidance on risk management, deviations, change control, and compliance strategies.Take an agile, solution-oriented approach to address quality challenges in a rapidly evolving biotech landscape.Ensure inspection readiness for health authorities and internal audits.Spearhead quality metrics, risk management, and continuous improvement initiatives to enhance compliance and efficiency.Own the GMP certification process, collaborating with regulatory authorities such as Swissmedic, EMA, and FDA.Drive supplier qualification, audits, CAPA management, and regulatory inspections.Build, mentor, and inspire a high-performance Quality team.Instil a proactive, solution-driven quality mindset throughout the company.Collaborate cross-functionally with R&D, Manufacturing, Clinical, and Regulatory teams to ensure seamless quality integration.Your Background:You hold a minimum M.Sc. in a biological field (e.g., Biology, Pharmacy/ Biotechnology/ Chemistry) or a comparable education with a minimum of 8+ years working experience in regulated industry in similar (manager level) position. Experience in the pharmaceutical industry with a good under-standing of biologics is preferred. You have a strong track record of successfully ensuring compliance with GMP standards. Additionally, you possess in-depth knowledge of regulatory requirements set by Swissmedic, EMA, and the FDA, along with hands-on experience in process validation, technology transfer, and supplier qualification.Desired Skills and Experience:Thrives in a high-growth, fast-paced biotech startup.Hands-on problem solver with a “get it done” attitude.A proactive approach to continuous improvement and risk management.Ability to work in a dynamic, evolving environment where agility is key.Effective communicator, able to align stakeholders and drive decision-making.Experience working within local jurisdictional and regulatory authorities.Strong coordination and organization skills, with strict emphasis on accuracy and attention to detail.Must have the ability to work within strict deadlines and under pressure while maintaining a professional demeanor.Proven experience in relevant roles, particularly as Qualified Person in Switzerland.Thorough knowledge of methodologies of quality assurance and standards.Excellent understanding of data analysis/statistical methods.Fluent in English and German, both oral and written. Italian/French is a plus.Place of workWe 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 environmentA young and dynamic team26 days of vacationsOne day off for your birthdayAre 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 EnglishCopies of degrees and referencesby using the following link:Apply OnlineThis recruitment is being carried out in collaboration with our HR partner, HC Solutions AG, Annika Danielsson.For further information regarding the role and the recruitment process, please contact CUTISS AG at info@cutiss.swiss.For this position, only direct applications will be considered.Seniority levelSeniority levelMid-Senior levelEmployment typeEmployment typeFull-timeJob functionJob functionQuality AssuranceReferrals increase your chances of interviewing at CUTISS AG by 2xSign in to set job alerts for “Quality Assurance Lead” roles.IT QA Quality Assurance Associate DirectorAssociate Director, Publication Data Systems & InnovationsAssociate Director, Publication Data Systems & InnovationsSenior TranSCend Business User Access ManagerBusiness Line MV Drives Service Operations Manager 80-100%Senior Quality Assurance Manager (m/f/d)(Junior) Quality Assurance Manager/Deputy fvP - part-timeSenior Quality Assurance Engineer - Engineering Tools(Senior) Design Quality Assurance EngineerSenior Product Security Architect - Bensheim, GermanyWe’re unlocking community knowledge in a new way. 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