Senior Quality Assurance GDP Specialist

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 doWe 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.
This role is responsible for independently managing core quality processes, including deviations, change control, complaints, temperature excursion assessments.
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 forSupporting the definition, implementation, and continuous improvement of Quality Systems aligned with GDP requirements and industry best practices.
Managing, executing and/or supporting the following processes:DeviationsCAPAChange ControlAudits (internal, supplier, and customer)Distribution ComplaintsSupplier QualificationCustomer/Wholesaler Bona FideQuality and Technical Agreements with Customers/SuppliersShipping and transportation validation activitiesEnsuring 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.
Ensuring quality risk management documentation is complete and up to date.
Managing or support recall operations promptlySupporting 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.
Overviewing subcontracted GDP‑impacting activities when delegated.
Supporting regulatory inspections and 3PL, customer audits.
Partecipating in the definition of Quality metrics (deviations, CAPA, Change Control, KPIs and others)Representing the Quality GDP department during internal and external meetings when delegated.
Performing Responsible Person responsibilities when required.
Deputizing for the GDP QA Manager as needed to ensure continuity of operations and compliance.
You will need to haveQualification in a scientific or technical discipline and /or more than 8 years relevant industry experienceKnowledge of Quality standards and Regulatory guidelines and requirements relating to pharmaceutical and/or biotech productsDemonstrated skills and experience in the conduct of Quality activities as described aboveExperience in project