Summary: The QA Compliance Team Leader supports effective GxP Compliance and/or Audit activities, operations and systems to ensure compliance of business areas with the Novartis Quality Manual and Policies and all relevant GxP, legal and regulatory requirements, and through internal audits, KPIs (Key Performance Indicators) and KQIs (Key Quality Indicators). Supports the preparation and management of external and corporate audits and Health Authority inspections. About the Role: Major accountabilities: - Planning and supporting PQR/APQR activities. - Support site qualification and validation activities (planning, advising, review). - Implementation of Quality Systems (incl. documentation management). - Supplier management activities (agreements, oversight, audit). - Preparation/support and coordination of CAPA/follow-up. - Audit and inspection preparation and support. - Change control review/approval. - Ensure local DI and eCompliance oversight (training, inspections, plan, risk ID etc.). - Ensure process quality assurance according to regulations. - Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt. Minimum Requirements: - Scientific degree. - Previous experience in a Quality Assurance department within a pharma manufacturing environment. - People management skills. - Fluent in Italian and English. Division Operations Business Unit Universal Hierarchy Node Location Italy Site Torre Annunziata Company / Legal Entity IT08 (FCRS = IT008) Novartis Farma S.p.A. Functional Area Quality Job Type Full time Employment Type Regular Shift Work No Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.