Overview In this role you will support the execution of audits (second and first party), qualify R&D; suppliers, and manage Quality Agreements to ensure GMP compliance for sterile, biological, and biotech products. You will collaborate with cross-functional teams and external consultants to drive quality assurance across supplier networks. The position offers hands-on audits, KPI data review, and SOP standardisation within a performance-driven, global R&D; context. This is a chance to contribute to high-stakes compliance in gene therapies and advanced platforms. Retribuzione / Benefits * annual premio * pension * private medical insurance * wellbeing programme * flexible benefits programme * relocation support Responsabilità * Plan and execute second party audits of GMP suppliers and GMP service providers (CMOs, contract laboratories) * Execute first party audits * Monitor corrective and preventive actions and ensure timely closure * Coordinate external consultants supporting Auditing & Supplier Qualification - GMP & Medical Device Unit * Define,



review and finalise Quality Agreements with GMP suppliers and service providers * Support hosting of GMP inspections * Collect and review data for Management Review and KPIs/metrics * Finalize and standardise SOPs related to auditing and supplier qualification processes * Organise and support training on GMP requirements and related procedures * Act as QA reference for audit and qualification activities involving sterile, biological and biotech products * Interact with CMC, Regulatory Affairs, Clinical Supply, Procurement and cross-functional teams to qualify providers Requisiti fondamentali * Scientific degree, preferably in Pharmacy, Chemistry, Biology, Biotechnology, Pharmaceutical Sciences or related discipline * At least three years of experience as auditor in pharmaceutical companies * Experience in Quality Assurance, supplier qualification or audit activities within pharmaceutical development or manufacturing * Knowledg

📌 QA GMP Senior Auditor (Reggio Emilia)
🏢 Chiesi
📍 Reggio Emilia