Quality & Compliance System Senior Specialist
Parma, IT
About us
Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Discover more here.
At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.
Diversity and inclusion are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better.
Global Technical Operations & Supply
Global Technical Operations & Supply (Global TechOp&S) is Chiesi’s global manufacturing and supply area, responsible for ensuring consistent, outstanding quality, service and value across our end‑to‑end supply chain. Global TechOp&S oversees the entire lifecycle of the drug: from process optimization and industrialization, to manufacturing, engineering, quality oversight, and supply chain management. Throughout this journey, Operational Excellence drives continuous improvement. This end‑to‑end model is powered by our four manufacturing sites - Parma (IT), Blois (FR), Santana de Parnaíba (BR), and Nerviano (IT) - together with our Virtual Plant network of external partners.
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 Quality & Compliance System Senior Specialist is responsible for the management and continuous improvement of the Quality Management System (QMS), with a particular focus on QMS-related projects. This key role ensures that all GMP-related processes are fully compliant with GMP standards, FDA and EU regulations, and internal company guidelines.
You’ll be responsible for:
- Developing and Implementing Quality Management Systems (QMS): this includes 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.
- Prepare and submit periodic reports on the performance of the quality management system to company management
- Working with Cross-Functional Teams: collaborate with other departments (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 preventative action plans.
- Quality System Governance: fostering a culture of quality and ongoing improvement throughout the site.
- Promote continuous improvements and share 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 teamworking 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
No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way.
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.
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