QA GCP & GVP Associate

Fondazione Telethon ETS (FT) is committed to developing therapeutic options for patients affected by rare genetic disorders. FT pipeline consists in various programs at different development stages (from pre-clinical to commercial). For such programs, Telethon is responsible, among others, to act as Sponsor in the conduction of clinical trials to assess safety and efficacy of Advanced Therapy Medicinal Products and as Marketing Authorization Holder in guaranteeing post-marketing pharmacovigilance. As QA GCP & GVP Associate, you will be part of the team that ensures compliance with Good Clinical Practice (GCP) and Good Vigilance Practices (GVP) guidelines, supporting the development and implementation of clinical trials and pharmacovigilance activities. Your main responsibilities will include: • Coordinating and participating in audits and inspections to ensure compliance with GCP and GVP regulations; • Developing and implementing procedures for the management of clinical trial data and documentation; • Collaborating with cross-functional teams, including Clinical Operations, Medical Affairs, and Regulatory Affairs; • Providing training and support to study sites and investigators on GCP and GVP guidelines; • Maintaining accurate records and reports related to clinical trials and pharmacovigilance activities. The ideal candidate will have a degree in Life Sciences or a related field, with at least 2 years of experience in the pharmaceutical industry, preferably in QA/GCP/GVP roles. Knowledge of Good Clinical Practice (GCP) and Good Vigilance Practices (GVP) guidelines is required.