Overview

In this role you lead and support GMP audits across integral sites and partners to verify compliance with Novartis Quality System and current GMP regulations. You drive audit planning, execution, and follow-up, and provide risk-based assessments to guide remediation. You collaborate with cross-functional teams, mentor junior staff, and serve as a GMP compliance consultant for trainings and improvements. A key focus is aligning audits with strategic direction while helping business units manage regulatory risk. You will travel up to 60% and engage in high-risk areas to influence quality and patient safety.

Responsabilidades

- Plan, conduct, document, and close GMP audits per Novartis procedures and regulatory requirements
- Lead complex, high-risk audits (sterile API, aseptic DP, combination products) and assess associated risks
- Provide technical guidance, mentoring, and training on audit activities
- Review corrective action plans and ensure timely remediation and escalation of critical findings
- Prepare audit reports and share best practices for auditor development
- Act as GMP consultant for trainings, task forces,



and continuous improvement projects
- Assess CAPA adequacy with QA representatives and auditees
- Maintain up-to-date knowledge of regulations, standards, and guidance

Requisitos principales

- 12+ years in Pharma or Medical Device industry
- 3+ years auditing experience preferred with strong regulatory knowledge
- Strong GMP knowledge and practical regulatory interpretation
- Solid operational experience in QA/QC management and manufacturing or regulatory authority exposure
- Experience in sterile operations or expertise in at least one area: DP manufacturing, laboratories, API, biologics, microbiology, computer system validation, quality systems, cell/gene therapy, radioligand therapy
- Strong interpersonal skills and diplomacy
- Ability to independently manage and assess complex compliance issues
- Fluent English (written and spoken); additional languages a plus

- diplomacy
- persuasion
- cross-functional collaboration
- GMP regulations
- audit execution and reporting
- risk-based auditing

📌 Global GMP Senior Quality Auditor (Barcelona)
🏢 Novartis
📍 Barcelona