PThe 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). /ppSupports the preparation and management of external and corporate audits and Health Authority inspections. /ppAbout the Role /ppbMajor accountabilities : /b /pulliPlanning and supporting PQR / APQR activities. /liliSupport site qualification and validation activities (planning, advising, review). /liliImplementation of Quality Systems (incl. documentation management). /liliPreparation / support and coordination of CAPA / follow-up. /liliAudit and inspection preparation and support. /liliChange control review / approval. /liliEnsure local DI and eCompliance oversight (training, inspections, plan, risk ID etc.). /liliEnsure process quality assurance according to regulations. /liliReporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt. /liliPrevious experience in a Quality Assurance department within a pharma manufacturing environment. /liliFluent in Italian and English. /li /ulpuWhy Novartis : /u Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? /ppJoin our Novartis Network : Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up : /ppNovartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. /ppJ-18808-Ljbffr /ppJ-18808-Ljbffr /p #J-18808-Ljbffr