Quality & Compliance System Senior Specialist
Pubblicato il 01-08-2026 - Chiesi Farmaceutici in Italia
Quality & Compliance System Senior Specialist
Department: Quality Operations Italy, Parma Site
Job Type: Direct Employee
Business Area: Quality
Contract Type: Permanent
Location: Parma, IT
This is what you will do
The Quality & Compliance System Senior Specialist, within the Quality & Compliance System group, is responsible for managing inspections, training, documentation, site compliance, quality KPIs, and the preparation of master documents such as raw materials, materials, and finished product release specifications. The role also manages and continuously improves the Quality Management System (QMS), focusing on GMP compliance, FDA and EU regulations, and internal guidelines.
You’ll be responsible for
- Developing and implementing Quality Management Systems (QMS): creating and updating procedures, processes, and documentation to meet quality standards.
- Monitoring and analyzing quality data: tracking quality metrics, identifying trends, and pinpointing areas for improvement.
- Preparing and submitting periodic reports on QMS performance to company management.
- Working with cross-functional teams (production, engineering, procurement) to resolve quality issues and improve processes.
- Investigating quality issues: analyzing root causes and developing corrective and preventive action plans.
- Fostering quality system governance and a culture of continuous improvement throughout the site.
- Promoting continuous improvements and sharing best practices to ensure compliance with company procedures.
You will need to have
- Degree in a scientific subject (Chemistry, Pharmaceutical Chemistry and Technology, Engineering).
- At least 5 years of experience in manufacturing sites within the pharmaceutical and biopharmaceutical sector, specifically in Quality Assurance, Production, and Process Technology departments.
- Excellent knowledge of pharmaceutical guidelines (EU and FDA regulations).
- Specialized expertise in GMP compliance improvement processes.
- Fluent English