Qa Gcp & Gvp Manager

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7f0tiv

ppFondazione 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.
/p pThe primary purpose of this role is to work closely with Clinical Operations and Pharmacovigilance functions to support compliance with GCP/GVP, applicable regulations, and the internal Quality Management System.
Key responsibilities also include service provider oversight, auditing, study risk management, and contributing to the maintenance of the FT Quality Management System (including deviation management, CAPAs, procedures, and change control).
/p pThe Quality Assurance Associate will interact closely with the other QA functions, the Clinical Development and Operations, Pharmacovigilance and Regulatory Affairs Units, and with clinical centers and external service providers.
/p h3RESPONSABILITIES /h3 ul liGuarantee GCP compliance throughout the management of clinical trial activities and study documents revision, both for interventional and non-interventional studies, in close collaboration with the Clinical Development and Operations Unit /li liGuarantee GVP compliance for commercial products,



in close collaboration with the Pharmacovigilance Unit /li liPerform, alone or in cooperation with SMEs and/or external consultants, qualification audits to service providers and study audits to clinical sites and TMF /li liImplement and maintain the study risk matrix in coordination with the other FT units.
/li liManage quality records such as external and internal non-compliances, change controls and CAPAs to evaluate and resolve quality issues and to enhance continuous improvement /li liCooperate with other QA functions in the development of quality metrics /li liCooperate with other QA functions in the validation of computerized systems /li liMaintain and improve the existing Quality Management System through writing/revision of SOPs/Working Instructions and oversight of personnel training to GCP and GVP-related documents and tasks; /li liBe involved in preparation and conduction of regulatory inspections and self-inspections.
/li /ul h3QUALIFICATIONS /h3 ul liDegree in a relevant scientific discipline; /li liAt least 5 years of previous experience in GCP and/or GVP Quality Assurance; /li liPrevious experience with ATMPs is a plus; /li liExcellent English oral and written communication; /li liAbility to work autonomously, prioritize workflow and collaborate in a cross-functional setting; /li liDemonstrated analytical, problem resolution and communication skills.
/li /ul h3Other Informations /h3 pSalary Range: *************** € /p /p #J-*****-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7f0tiv