Overview

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 general 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 global 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 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