QA GCP & GVP Manager

Fondazione Telethon; Milano; In loco; EUR 40.000 - 45.000; Tempo pieno

Descrizione del lavoro

Fondazione Telethon is seeking a Quality Assurance Associate to partner with Clinical Operations and Pharmacovigilance, ensuring GCP/GVP compliance across studies and vendors. You will contribute to risk management, audits, and continuous improvement within the FT Quality Management System.

You will interact with Clinical Development, QA, and external providers, maintaining SOPs and supporting inspections while advancing regulatory readiness and post-marketing vigilance.

Competenze

• Degree in a relevant scientific discipline.
• At least 5 years of experience in GCP and/or GVP Quality Assurance.
• ATMPs experience is a plus.
• Excellent English oral and written communication.
• Ability to work autonomously, prioritize workflow and collaborate cross-functionally.
• Demonstrated analytical, problem resolution and communication skills.

Mansioni

• Guarantee GCP compliance throughout management of clinical trial activities and study documents revision, for interventional and non-interventional studies.
• Guarantee GVP compliance for commercial products in collaboration with Pharmacovigilance Unit.
• Perform qualification audits of service providers and study audits to clinical sites and TMF, alone or with SMEs or external consultants.
• Implement and maintain the study risk matrix in coordination with FT units.
• Manage quality records such as non-compliances, change controls and CAPAs to improve quality.
• Collaborate with other QA functions in development of quality metrics.
• Collaborate with QA in validation of computerized systems.
• Maintain and revise SOPs/Working Instructions and oversee training on GCP and GVP documents.
• Assist in regulatory inspections and self-inspections.

Conoscenze

Excellent English

Autonomous work

Prioritization

Analytical skills

Cross-functional collaboration

Problem solving

Formazione

Degree in a relevant scientific discipline

Descrizione del lavoro

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.

The 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).

The 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.

RESPONSABILITIES:

• Guarantee 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
• Guarantee GVP compliance for commercial products, in close collaboration with the Pharmacovigilance Unit
• Perform, alone or in cooperation with SMEs and/or external consultants, qualification audits to service providers and study audits to clinical sites and TMF
• Implement and maintain the study risk matrix in coordination with the other FT units.
• Manage quality records such as external and internal non-compliances, change controls and CAPAs to evaluate and resolve quality issues and to enhance continuous improvement
• Cooperate with other QA functions in the development of quality metrics
• Cooperate with other QA functions in the validation of computerized systems
• Maintain 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;
• Be involved in preparation and conduction of regulatory inspections and self-inspections.

Qualifications

• Degree in a relevant scientific discipline;
• At least 5 years of previous experience in GCP and/or GVP Quality Assurance;
• Previous experience with ATMPs is a plus;
• Excellent English oral and written communication;
• Ability to work autonomously, prioritize workflow and collaborate in a cross-functional setting;
• Demonstrated analytical, problem resolution and communication skills.

Other Informations

Salary Range: 40.000 – 45.000 €