Overview In this role you will lead and perform GMP audits to ensure compliance with Novartis Quality System and current regulations. You will work on internal and external audits across sites, functions, and suppliers, shaping a integral audit strategy and supporting risk-based improvements. You will mentor staff, provide regulatory guidance, and drive timely remediation of findings. This position offers remote work with significant travel (up to 60%) and relocation support, with opportunities to impact quality programs at a global scale.

Compensaciones / Beneficiosflexible and hybrid working optionsinsurance plansretirement planswellbeing resourcesglobal recognition programs14 weeks paid parental leave ResponsabilidadesPlan, lead, and document GMP audits per Novartis Quality procedures and regulatory requirementsReview and approve CAPAs and corrective action plans for audit findingsAudit diverse targets (manufacturing sites, development centers, contract manufacturers, labs, warehouses, suppliers)Provide technical guidance, mentoring,



and training to audit teamsDeliver audit reports within timelines and communicate findingsMentor junior GMP staff and support continuous improvement initiativesEscalate critical findings to management and coordinate follow-up actionsAssess adequacy of responses to audit findings in collaboration with QA and AuditeeMaintain current knowledge of regulations and standardsSupport development and execution of a global risk-based audit strategy and program Requisitos principales12+ years of experience in Pharmaceuticals or Medical Devices3 years auditing experience preferredStrong knowledge of GMP regulations and regulatory requirementsOperational experience in QA/QC management, manufacturing, or regulatory health authority environmentsExperience in sterile operations or in DP Manufacturing, API, Biologics, or related domainsExcellent interpersonal skills and ability to influence stakeholdersFluent in English (written and spoken); additional languages are a plusIndependent management of complex compliance issues with minimal supervisionExperience with regulatory guidance for filings and risk assessmentdiplomacy and persuasioncross-functional collaborationstrong communication and mentoringGMP auditing and internal auditingRegulatory compliance and quality systems (QMS)CAPA management and effectiveness assessment

📌 Senior Global GMP Quality Auditor - Novartis (Barcelona)
🏢 Jobrapido
📍 Barcelona