Quality & Compliance System Senior Specialist

ppIn this role you will lead and optimize the Quality Management System to ensure GMP, FDA and EU compliance across the site. You will partner with cross-functional teams to drive quality improvements, manage inspections, training, and documentation, and report on QMS performance. You will enable a culture of quality and continuous improvement, shaping robust processes for materials, manufacturing, and release specifications. This is a chance to contribute to a globally recognized biopharmaceutical group focused on sustainable health outcomes. /pullicomprehensive healthcare programs /liliwork-life balance initiatives /lilirelocation support /liliflexible working arrangements /liliremote work options /liliDevelop and implement QMS processes, procedures, and documentation to meet quality standards /liliMonitor and analyze quality data, identify trends, and drive improvement actions /liliPrepare periodic QMS performance reports for management /liliCollaborate with production, engineering, procurement and other functions to resolve quality issues /liliInvestigate quality problems, identify root causes, and implement corrective and preventive actions (CAPA) /liliGovern and promote a culture of quality and continuous improvement across the site /liliShare best practices and ensure activities comply with company procedures /liliDegree in scientific subjects (Chemistry, Pharmaceutical Chemistry and Technology, Engineering) /liliAt least 5 years of pharmaceutical/biopharmaceutical experience in QA, Production, and Process Technology /liliExcellent knowledge of EU and FDA pharmaceutical guidelines /liliSpecialized expertise in GMP compliance improvement processes /liliFluent English (written and spoken) /liliStrong teamwork and cross-functional collaboration /liliAnalytical thinking with ability to assess technical issues and propose shared solutions /liliEffective communication and stakeholder management /liliQMS development and governance /liliQuality data analysis and trend identification /liliRoot cause analysis and CAPA implementation /li /ulpQuality Compliance System Senior Specialist napoli, campania, it /p /p #J-18808-Ljbffr