The Company
AAVantgarde is a clinical-stage, international biotechnology company headquartered in Italy. We have developed two cutting-edge AAV vector platforms to overcome DNA cargo limitations, targeting Usher syndrome type 1B and Stargardt disease. Founded by the renowned Professor Alberto Auricchio, a pioneer in gene therapy, our mission is to transform genetic medicine for patients with no current therapeutic options. Join us at AAVantgarde and be a part of our innovative journey to bring the next generation of genetic medicines to those in need.
The Role
We are seeking an experienced Clinical Quality Assurance leader to establish and oversee a fit-for-purpose CQA function at AAVantgarde. Reporting to the Head of Quality, this role is central to ensuring that all clinical research activities comply with ICH-GCP, EU Clinical Trials Regulation, and local regulatory requirements. You will be responsible for developing and continuously improving our clinical quality systems, providing strategic input into R&D processes, and preparing the organisation for regulatory inspections.
As the companys subject matter expert in clinical quality, you will lead internal and external audits, manage CAPA processes, and support clinical teams in interpreting and applying GCP standards. You will also oversee GCP training, advise senior management on...