Global Good Clinical Practices (Barcelona)

Global Good Clinical Practices (Barcelona)

16 sep
|
Novartis
|
Barcelona

16 sep

Novartis

Barcelona

Overview
As a General 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
- 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 guidel

📌 Global Good Clinical Practices (Barcelona)
🏢 Novartis
📍 Barcelona

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