PThe QA Compliance Team Leader supports effective GxP Compliance and Audit activities to ensure business areas adhere to the Novartis Quality Manual, Policies, and all relevant GxP legal and regulatory requirements. This includes monitoring through internal audits, KPIs, and KQIs. /ppResponsibilities include preparing for and managing external and corporate audits and Health Authority inspections. /ppMajor accountabilities: /pollibPlanning and supporting PQR / APQR activities. /b /liliSupporting site qualification and validation activities, including planning, advising, and review. /liliImplementing Quality Systems, including documentation management. /liliManaging supplier activities, including oversight of agreements and audits. /liliPreparing, supporting, and coordinating CAPA processes and follow-up. /liliSupporting audit and inspection preparations. /lilibReviewing and approving change controls. /b /liliEnsuring local DI and eCompliance oversight, including training, inspections, planning, risk identification, etc. /lilibEnsuring process quality assurance in compliance with regulations. /b /liliReporting technical complaints, adverse events, and special case scenarios related to Novartis products within 24 hours of receipt. /li /olpMinimum requirements: /pulliPrevious experience in a Quality Assurance department within a pharmaceutical manufacturing environment. /liliFluency in Italian and English. /liliKnowledge of GMP procedures, GxP industry standards, process optimization, quality assurance, and related technological expertise. /li /ulpKey skills include familiarity with Hyperion, Acquisition, Asset, ABAP, Basic, ActiveX, among others. /ppuEmployment Type: /u Full-Time /ppuExperience: /u Years (please specify) /ppuVacancy: /u 1 /p #J-18808-Ljbffr