Overview In 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 / Benefits
* comprehensive healthcare programs
* work-life balance initiatives
* relocation support
* competitive salary
* flexible working arrangements
* remote work options Responsabilità
* Develop and implement QMS processes, procedures, and documentation to meet quality standards
* Monitor and analyze quality data, identify trends, and drive improvement actions
* Prepare periodic QMS performance reports for management
* Collaborate with production, engineering, procurement and other functions to resolve quality issues
* Investigate quality problems,
identify root causes, and implement corrective and preventive actions (CAPA)
* Govern and promote a culture of quality and continuous improvement across the site
* Share best practices and ensure activities comply with company procedures Requisiti fondamentali
* Degree in scientific subjects (Chemistry, Pharmaceutical Chemistry and Technology, Engineering)
* At least 5 years of pharmaceutical/biopharmaceutical experience in QA, Production, and Process Technology
* Excellent knowledge of EU and FDA pharmaceutical guidelines
* Specialized expertise in GMP compliance improvement processes
* Fluent English (written and spoken)
* Strong teamwork and cross-functional collaboration
* Analytical thinking with ability to assess technical issues and propose shared solutions
* Effective communication and stakeholder management
* QMS development and governance
* Quality data analysis and trend identification
* Root cause analysis and CAPA implementation
📌 Quality & Compliance System Senior Specialist (Veneto)
🏢 Chiesi
📍 Veneto