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 (La Spezia)
🏢 Chiesi
📍 La Spezia