21 set - Casagiove
Chiesi
OverviewIn 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.Retribuzione / Benefitscomprehensive healthcare programswork-life balance initiativesrelocation supportcompetitive salaryflexible working arrangementsremote work optionsResponsabilitàDevelop and implement QMS processes, procedures, and documentation to meet quality standardsMonitor and analyze quality data, identify trends, and drive improvement actionsPrepare periodic QMS performance reports for managementCollaborate with production, engineering, procurement and other functions to resolve quality issuesInvestigate quality problems,
identify root causes, and implement corrective and preventive actions (CAPA)Govern and promote a culture of quality and continuous improvement across the siteShare best practices and ensure activities comply with company proceduresRequisiti fondamentaliDegree in scientific subjects (Chemistry, Pharmaceutical Chemistry and Technology, Engineering)At least 5 years of pharmaceutical/biopharmaceutical experience in QA, Production, and Process TechnologyExcellent knowledge of EU and FDA pharmaceutical guidelinesSpecialized expertise in GMP compliance improvement processesFluent English (written and spoken)Strong teamwork and cross-functional collaborationAnalytical thinking with ability to assess technical issues and propose shared solutionsEffective communication and stakeholder managementQMS development and governanceQuality data analysis and trend identificationRoot cause analysis and CAPA implementation
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