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. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose.

As a Agevolazioni Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact. We believe our differences make us stronger.

Global Technical

Operations & Supply Global Technical Operations & Supply (Global Tech Op&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. 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 We are seeking an experienced and highly motivated Senior GDP QA Specialist to support and strengthen our Good Distribution Practice (GDP) Quality Management System within a dynamic pharmaceutical environment. Reporting to the GDP QA Manager, the successful candidate will operate with a high degree of autonomy, taking ownership of key GDP Quality Assurance activities and making sound, risk-based decisions to ensure regulatory compliance and business continuity. The successful candidate will be expected to proactively identify quality and compliance risks, drive continuous improvement initiatives,



and exercise independent judgment in resolving complex quality issues while ensuring alignment with GDP requirements and internal stakeholders requests.

This is an excellent opportunity for a quality professional with strong GDP expertise, excellent analytical and problem-solving skills, and a proven ability to work independently, prioritize competing demands, and make timely, risk-based decisions while maintaining the highest standards of product quality, regulatory compliance, and patient safety. You will be responsible for Supporting the definition, implementation, and continuous improvement of Quality Systems aligned with GDP requirements and industry best practices. Deviations CAPAChange Control Audits (internal, supplier, and customer)Distribution Complaints Supplier Qualification Customer/Wholesaler Bona Fide Quality and Technical Agreements with Customers/Suppliers Shipping and transportation validation activities Ensuring proper record retention in accordance with GDP and internal standards.

Participating in investigations and support the implementation and effectiveness check of Corrective Action Preventative Action. Managing or support recall operations promptly Supporting the evaluation and management of returned, rejected, recalled, or falsified products.



Reviewing temperature excursions and support the suitability assessment for product release or rejection.

Ensuring customer complaints are handled efficiently and documented appropriately. Supporting regulatory inspections and 3 PL, customer audits. Deputizing for the GDP QA Manager as needed to ensure continuity of operations and compliance.

You will need to have Qualification in a scientific or technical discipline and /or more than 8 years relevant industry experience Knowledge of Quality standards and Regulatory guidelines and requirements relating to pharmaceutical and/or biotech products Demonstrated skills and experience in the conduct of Quality activities as described above Experience in project management, analytical, problem-solving Good prioritization capability and comfortable adapting to meet changing priorities Ability to manage urgent situations effectively and rapidly switch focus between multiple topics and priorities as business needs evolve Demonstrated ability to work autonomously, exercise sound judgment, and make timely, risk-based decisions Excellent interpersonal skills and collaboration skills to optimise relationships with internal and external partners We would prefer for you to have Comfortable working in an environment where the QMS will expand and grow in support of company growth Strong time management skills Willingness to learn and continuously improve skills Experience working with pharmaceutical products for rare diseases (orphan drugs) is considered a strong advantage Location The primary work location is Parma (Italy). The role offers flexibility, allowing candidates to be based across Europe, with regular travel to Parma required.

📌 Senior quality assurance gdp specialist (Parma)
🏢 Chiesi
📍 Parma