Experteer Overview In this role you help design, maintain, and continually improve the site’s quality systems to meet regulatory and GMP requirements. You work with cross-functional teams to ensure procedures are followed and readiness for inspections is maintained. You will influence the quality management program and support audits by coordinating responses and corrective actions. Your impact spans compliance, risk, and process improvements that sustain a robust quality infrastructure.Compensaciones / Beneficios - Maintain and improve the site quality system to meet regulatory and GMP requirements - Oversee documentation management, reviews, updates, and approvals of site quality system documents - Manage nonconformances, CAPAs, change controls, training, inspections, audit readiness, and risk assessments - Support design and oversight of strategic quality system initiatives and written procedures across functions - Lead audit and inspection management, including preparation, responses, and interactions - Support health authority inspections and global audits;
develop communications and responses to observations - Escalate quality/gCGMP issues to Site QA Head and support global escalation processes - Coordinate with Novartis network for health authority notifications (e.G., FAR, rapid alerts, recalls) - Ensure robust quality systems and deviations/CAPA management are well-documented and investigated - Support annual product quality review and self-assessments;
monitor KPIs and quality management reviewsResponsabilidades - Bachelors Degree in Pharmacy or MSc in Pharmaceutical Industry - 2+ years in a GxP (Bio)pharmaceutical or API manufacturing environment - 1+ year in a Quality Assurance role - Excellent communication skills in English and Spanish (written and spoken)Requisitos principales -