Overview
Aumente sus posibilidades de llegar a la fase de entrevista leyendo la descripción completa del puesto y enviando su solicitud sin demora.
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 xqbhyrx
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