Quality & Compliance System Senior Specialist
Pubblicato il 17-09-2026 - Chiesi in Novara
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