OverviewIn 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 integral 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 / Beneficiosflexible and hybrid working options insurance plans retirement plans wellbeing resources global recognition programs

14 weeks paid parental leave

ResponsabilidadesPlan, 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 global risk-based audit strategy and program

Requisitos principales12+ 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