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 global 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 / Beneficios

- flexible and hybrid working options
- insurance plans
- retirement plans
- wellbeing resources
- global recognition programs
- 14 weeks paid parental leave

Responsabilidades

- Plan, lead, and document GMP audits per Novartis Quality procedures and regulatory requirements
- Review and approve CAPAs and corrective action plans for audit findings
- Audit diverse targets (manufacturing sites, development centers, contract manufacturers, labs, warehouses, suppliers)
- Provide technical guidance, mentoring, and training to audit teams
- Deliver audit reports within timelines and communicate findings
- Mentor junior GMP staff and support continuous improvement initiatives




- Escalate critical findings to management and coordinate follow-up actions
- Assess adequacy of responses to audit findings in collaboration with QA and Auditee
- Maintain current knowledge of regulations and standards
- Support development and execution of a integral risk-based audit strategy and program

Requisitos principales

- 12+ years of experience in Pharmaceuticals or Medical Devices
- 3 years auditing experience preferred
- Strong knowledge of GMP regulations and regulatory requirements
- Operational experience in QA/QC management, manufacturing, or regulatory health authority environments
- Experience in sterile operations or in DP Manufacturing, API, Biologics, or related domains
- Excellent interpersonal skills and ability to influence stakeholders
- Fluent in English (written and spoken); additional languages are a plus
- Independent management of complex compliance issues with minimal supervision
- Experience with regulatory guidance for filings and risk assessment

- diplomacy and persuasion
- cross-functional collaboration
- strong communication and mentoring
- GMP auditing and internal auditing
- Regulatory compliance and quality systems (QMS)
- CAPA management and effectiveness assessment

📌 Senior Global GMP Quality Auditor - barcelona
🏢 Novartis
📍 Barcelona