OverviewIn this role you ensure GCP compliance across Global R&D; by managing CAPAs, quality metrics, and audit programs. You will drive the documentation and process controls that support audit readiness and supplier qualification. You work closely with cross-functional teams to sustain a robust quality system and enable compliant clinical trials. The position offers a hybrid setup at the Parma HQ within a values-driven, sustainability-minded organization.

Retribuzione / Benefits

pensionprivate medical insurancewellbeing programmeflexible benefits programmeremote work optionsrelocation support

Responsabilità

Manage GCP CAPA plans and follow-upCoordinate collection of quality metrics and KPIs for Global R&DOversee; Trackwise, supplier,



and audit workflowsSupport external consultants in the Auditing & Supplier Qualification UnitFinalize Quality Documents for the unitWrite/Review SOPs related to audit and qualification of clinical service providersProvide training on relevant activities and proceduresEnsure documentation traceability and audit report finalization

Requisiti fondamentali

At least 3 years of experience in Pharmaceutical, Consultancy, or CRO in Quality Assurance for R&D; with strong GCP knowledgeKnowledge of GCP requirements and quality systemsUnderstanding of the pharmaceutical development process supporting clinical trialsExperience with training techniquesScientific degreeGood knowledge of EnglishClear communicatorAttention to detailTeam collaborationGCP knowledgeQuality system proficiencyCAPA management

📌 GCP specialist R&D Auditing Department (Roma)
🏢 Chiesi
📍 Roma