Quality Assurance GCP Assistant

Fondazione Telethon ETS is committed to developing therapeutic options for patients affected by rare genetic disorders. Telethon pipeline consists in various programs at different development stages (from pre-clinical to commercial). For such programs, Telethon is responsible, among others, for the conduction of clinical trials to assess safety and efficacy of Advanced Therapy Medicinal Products.

The primary objective of this position is to support the QA Unit in the maintenance, management and development of Telethon Quality Management System, with particular relevance to aspects related to GCP Quality Assurance.

The Quality Assurance Assistant will interact closely with the other QA functions, the Clinical development and operations Unit, and with external vendors.

Responsibilities

• Support the QA unit in the quality oversight of external GCP vendors, with particular relevance to: suppliers qualification; handling of external quality events; handling the oversight of CROs and providers for clinical trials;
• Support the QA unit in the management of internal change controls and non-compliances, including root cause investigations, to evaluate and resolve quality issues and to enhance continuous improvement;
• Support the QA unit during external audit to vendors and clinical sites;
• Support the QA unit in the maintenance and improvement of the existing Quality Management System through writing/revision of SOPs/WIs;
• Collaborate with the Clinical development and operations unit for the maintenance of GCP compliance throughout the management of the clinical trials activities;
• Support the QA unit in personnel training to GCP/GXP-related documents and tasks;
• Assist the QA unit in the preparation and conduction of regulatory inspections and self-inspections;
• Implement and maintain the study risk matrix.

• Degree in a relevant scientific discipline;
• Previous experience in Quality Assurance, preferably GCP;
• Previous experience with ATMPs is a plus;
• Excellent English oral and written communication;
• Ability to work autonomously and prioritize workflow;
• Demonstrated analytical, problem resolution and communication skills.

Salary

RAL and type of contract will be commensurate with seniority.

Workplace

Milan, hybrid.

We will only consider candidates who will attach their Resume when applying.

We thank you in advance for expressing your interest in the Organization. We inform you that, due to the huge amount of applications received, we will be able to provide a feedback only to those who will be contacted from Fondazione Telethon.

Fondazione Telethon is one of Italy’s leading non-profit organisations. Our mission is to invest in the best scientific research to arrive at a cure for rare genetic diseases. For these diseases, precisely because of their rarity, there is often no research, no therapies, no cure. We want to change this state of affairs because every person is important to us.