PpJoin to apply for the TRD Quality Manager role at Novartis Contract Manufacturing /ppb3 weeks ago Be among the first 25 applicants /b /ppGet AI-powered advice on this job and more exclusive features. /ph3Responsibilities /h3ulliSupport 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 responsibility /liliWrite 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. /liliManage 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. /liliSupport Project management functions as a project team member. /liliProvide support to TRD line functions in GMP related topics as per area of responsibility. /liliComply with internal and external guidelines regarding quality and safety (Quality Manual, regulatory cGMP guidelines, Health Authority guidance, SOPs etc.). /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. /li /ulh3Essential Requirements /h3ulliDegree 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 /ulh3About Novartis /h3pWhy 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! /ppNovartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. /p /p #J-18808-Ljbffr