Overview In this role, you will strengthen vendor operations for regulatory inspections and audits within Global Clinical Operations. You will bring subject-matter expertise to inspection readiness, audit support, CAPA, and vendor compliance across general partnerships. By leveraging compliance data and trends, you’ll drive risk reduction and process improvements to meet Novartis standards. You’ll collaborate with cross-functional teams to embed regulatory excellence and effective communications, while shaping how we prepare for inspections and ensure high-quality vendor performance.

Compensaciones / Beneficiosinsurance plansretirement planswellbeing resourcesglobal recognition programsflexible and hybrid workingminimum 14 weeks paid parental leave ResponsabilidadesDevelop and implement vendor operations standards, processes, and governance frameworksLead inspection readiness and support regulatory inspection activities across vendor partnershipsEnsure consistent vendor risk assessment, selection, and compliance processesOversee vendor quality metrics, identify trends and improvement opportunitiesDevelop templates, tools, and resources for vendor governance and complianceSupport audit planning, preparation, and follow-up,



including CAPA managementAct as a subject-matter expert on vendor compliance and quality managementPartner with global and local stakeholders to strengthen operational consistency and regulatory complianceDrive continuous improvement to enhance vendor performance and inspection readinessDeliver training and communications to support adoption of systems and compliance requirements Requisitos principalesUniversity degree in business or relevant field, or equivalent professional experienceTypically 8-10+ years’ experience in clinical operations, including systems, regulatory requirements, and third-party/vendor managementStrong knowledge of GCP and GxP regulations (ICH)Demonstrated experience supporting/regulatory inspections and managing back-room activitiesExperience with inspection readiness, evidence collection, and regulatory document requestsExperience supporting audits and developing/managing CAPAsStrong understanding of clinical trial design, vendor compliance, and third-party requirementsProven global matrix leadership, independent ownership, analytical decision-making, and diplomatic stakeholder influencediplomatic stakeholder influenceanalytical decision-makingcross-functional collaborationGCPGxP complianceGxP regulations

📌 Vendor Operations Lead - Global Clinical Operations (GCO) (Barcelona)
🏢 Jobrapido
📍 Barcelona