P1. Support a discipline and/or provide a service individually or within a team of associates. May provide functional expertise to Line Unit and other QA Units in area of responsibilitybr2. Write review, decide on approval and/or release of GMP-relevant deliverables, as applicable, and/or related tools as per area of responsibility in order to ensure compliance with cGMP and project quality deliverables.br3. Manage project related activities (e.g. TRD product portfolio, development of new tools, processes, Quality initiatives, Quality Manual implementation, Quality Plans, Quality Risk Assessments, training activities, qualification and facility upgrade activities, IT validation projects) as per area of responsibility.br4. Support Project management functions as a project team member.br5. Provide support to TRD line functions in GMP related topics as per area of responsibility.br6. Comply with internal and external guidelines regarding quality and safety (Quality Manual, regulatory cGMP guidelines, Health Authority guidance, SOPs etc.). /ph3About the Role /h3pbKey responsibilities: /b /pulliSupport the TRD QA function within a team, providing expertise to Line Units and other QA units in areas of responsibility. /liliWrite, review, and ensure compliance of GMP-relevant deliverables and tools with cGMP standards and project quality requirements. /liliOversee quality assurance for technical activities during development stages, including technical transfers and release requirements. /liliSupport project-related activities such as process development, quality initiatives, risk assessments, facility upgrades, and IT validation. /liliEnsure alignment and consistency of regulatory submissions (IMPD/IND, NDA/MAA) and address health authority queries. /liliAssist clinical trial teams with QA activity timelines and supply chain oversight. /liliPerform QMS-related activities, including training, KPI oversight, SOP maintenance, and audit/inspection support. /liliAct as QA point-of-contact for assigned CMO, including audits, CAPAs, documentation reviews, and compliance monitoring. /liliDegree in Pharmacy, Biology, Chemistry, Engineering, or equivalent. /liliFluency in English (verbal and written). /liliStrong awareness of quality issues and urgency in task completion. /liliOpen and clear collaboration and communication skills. /liliScientific, technical, and regulatory knowledge in the specific area, with basic understanding of drug development. /liliDetailed knowledge of cGMP and familiarity with safety/environmental regulations. /liliMinimum 5 years of experience in pharmaceutical companies in equivalent roles. /liliStrong organizational skills. /li /ulpWhy Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: will receive: You can find everything you need to know about our benefits and rewards in the Novartis Life /ppHandbook. to Diversity and Inclusion /b: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. /ppbJoin our Novartis Network: /bIf this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: /ppstrongWhy Novartis: /strong 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? /ppstrongJoin our Novartis Network: /strong 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: /ppIT58 (FCRS = IT058) Advanced Accelerator Applications Italy Srl /ppFunctional Area Quality /ppJob Type Full time /ppEmployment Type Regular /ppShift Work No /ppNovartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. /ph3Privacy Preference Center /h3h3Manage Consent Preferences /h3pAlways Active /ppIf you provided your email for marketing or disease awareness purposes, you may need to provide further information to enable us to fully honor your preferences. Click here to learn more. /p #J-18808-Ljbffr