Quality & Compliance System Senior Specialist

Quality & Compliance System Senior Specialist

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. This role also focuses on the management and continuous improvement of the Quality Management System (QMS), ensuring that all GMP‑related processes comply with FDA and EU regulations and internal company 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 the performance of the quality management system to company management.
• Working with cross‑functional teams (e.g., production, engineering, procurement) to resolve quality issues and improve processes.
• Investigating quality issues: analyzing root causes of quality problems and developing corrective and preventive action plans.
• Quality system governance: fostering a culture of quality and ongoing improvement throughout the site.
• Promoting continuous improvements and sharing best practices, ensuring that quality activities are carried out in compliance with company procedures.

You will need to have:

• Degree in scientific subjects (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 (both written and spoken).

We would prefer for you to have:

• Ability to establish strategies for managing multiple projects efficiently and effectively.
• Strong teamwork skills, contributing positively and constructively to achieving goals.
• Capacity to analyze technical issues and find shared solutions, evaluating related risks.

Location

Parma

What we offer

We provide top‑class benefits, including comprehensive healthcare programs, work‑life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive.

Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination.