15 sep
|
Novartis
|
Barcelona
15 sep
Novartis
Barcelona
Overview
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As a Global GCP/PV Auditor, you will ensure clinical and pharmacovigilance activities meet regulations and Novartis standards. You will plan, lead and report independent audits, support CAPA activities, and drive continuous quality improvements across global operations. The role involves stakeholder guidance, training, and collaboration with cross-functional teams to uphold GCP/GPvP compliance. This position offers remote work within Spain with travel up to 50% and relocation support.
Compensaciones / Beneficios
flexible and hybrid working options
minimum 14 weeks paid parental leave
insurance plans
retirement plans
wellbeing resources
general recognition programs
Responsabilidades
Plan, lead, conduct, document, and follow up on GCP/PV audits in line with Novartis procedures and regulations
Perform low-risk audits (investigator site, single-service vendors, systems/process, patient-oriented programs)
Support complex audits (country organizations, multiservice vendors, high-risk vendors)
Provide technical guidance and training to ensure consistent audit execution and quality
Escalate critical findings and coordinate immediate follow-up actions
Define and follow up on mitigation plans; assess CAPA responses with CAPA Approvers/Coordinators
Maintain up-to-date knowledge of applicable regulations, standards, and industry expectations
Requisitos principales
Degree in natural or biological sciences or equivalent experience
Approximately 5 years of experience in GCP, GPvP, clinical research or pharmaceutical xqbhyrx environment
1–2 years of GCP auditing experience preferred
Strong knowledge of GCP, GPvP, and GxP regulations and procedures
Ability to manage multiple priorities and work independently with sound decision-making
Strong quality, compliance mindset and stakeholder engagement skills
Fluent English; additional languages advantageous
Leadership
Stakeholder engagement
Facilitation
GCP/GPvP/GxP regulations and guidelines
Audit management and CAPA processes
Quality assurance training and guidance
📌 Global Good Clinical Practices / Pharmacovigilance Auditor (Barcelona)
🏢 Novartis
📍 Barcelona