Overview

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 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 company’s 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

• Bachelor’s degree in Life Sciences or Biotechnology (advanced degree preferred).
• Minimum 7–10 years of experience in clinical QA within biotech or pharmaceutical industry.
• Strong knowledge of ICH-GCP, EU Clinical Trials Regulation, and local regulatory frameworks.
• Experience preparing for and leading regulatory inspections.
• Understanding of clinical trial operations and quality risk management.
• Ability to work in a cross-functional, matrixed environment, ideally in a small or start-up biotech.
• Strong communication, leadership, and problem-solving skills.
• Experience with clinical records management systems and data integrity principles.
• Confidence in delivering specialist GCP training and influencing stakeholders.

Commitment to Equality and Recruitment Policy

AAVantgarde is committed to equal opportunity employment and does not discriminate on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or any other legally protected characteristic. All applicants will receive equal consideration for employment.

Recruitment Policy

AAVantgarde’s HR team leads all recruitment activities globally. Unsolicited resumes do not create a relationship or obligate payment of fees. External recruiters and agencies should not contact hiring managers or employees directly. For partnership inquiries, please email recruitment@aavantgarde.com.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Quality Assurance

Industries

• Biotechnology Research and Pharmaceutical Manufacturing