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 compliance risks, and build quality metrics dashboards to support decision-making. This role requires close collaboration across functions to embed a culture of quality and ensure the integrity and compliance of clinical trial data. You will also play a key role in evaluating and selecting external clinical service providers from a quality perspective.

Skills and Experience Required

To thrive in this role, you will need to bring deep expertise in clinical quality assurance, along with a proactive and hands-on approach. You should have a bachelors degree in a relevant field such as Life Sciences or Biotechnology, with an advanced degree preferred. A minimum of seven to ten years of experience in clinical QA within the biotech or pharmaceutical industry is essential, along with a comprehensive understanding of ICH-GCP, EU Clinical Trials Regulation, and local regulatory frameworks.

You will have experience preparing for and leading regulatory inspections, and a strong grasp of clinical trial operations and quality risk management. The ability to work effectively in a cross-functional, matrixed environmentideally within a small or start-up biotechis key. Strong communication, leadership, and problem-solving skills are required, as is experience with clinical records management systems and data integrity principles. You should also be confident in delivering specialist GCP training and influencing stakeholders across the organisation.

Equal Opportunities

At AAVantgarde, we are committed to fostering a welcoming, collaborative, and inclusive environment. We believe in providing equal opportunities for all and do not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender idenittity, national origin, disability, or any other legally protected characteristics. All applicants will receive equal consideration for employment.

Recruitment Policy

AAVantgardes HR team leads all recruitment activities for AAVantgarde globally. AAVantgarde will not recognise any notional ownership recruitment companies claim to hold over candidates they present directly to hiring managers without the AAVantgarde HR teams consent, nor any fees the recruitment company may feel are due as a result of this. Unsolicited resumes sent to AAVantgarde from recruiters do not constitute any type of relationship between the recruiter and AAVantgarde and do not obligate AAVantgarde to pay fees should we hire from those resumes. We ask that external recruiters and/or agencies not contact or present candidates directly to our hiring managers or employees.

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