Summary
In this role you will lead, support and report independent GMP audits according to the Novartis Quality System and the current GMP regulations to assess compliance with applicable regulations, standards, and guidance documents. Review and approve corrective action plans in support of the audit observations. The audits performed include internal and external targets of manufacturing sites, development centers, quality systems, contract manufacturers, laboratories, warehouses, country organizations, and suppliers. The Global GMP Senior Quality Auditor also ensures alignment with strategic direction of the company and assists in driving implementation of the applicable actions and provides consultation to Novartis business units through risk based assessments.
About The Role
In this role you will be required to travel up to 60% of time.
Major Accountabilities

Support the strategic development of an effective integral risk-based audit strategy and program. Collect, collate, and incorporate input into the audit strategy and plan.
Plan, lead, conduct, document,



and follow-up of GMP audit according to the requirements specified in the respective Novartis Quality procedures as well as applicable regulations, standards, quality agreements, and guidance documents.
For this role, auditors will be given more complex and higher-risk audits, such as sterile API, aseptic DP, and combination products. The ability to assess risk of these operations is critical to success. Provide technical guidance, mentoring, and training on audit activities.
Provide regulatory guidance for timely remediation and recommendations regarding acceptability of the proposed filing.
Prepare audit reports according to NVS requirements and timelines. Identify and report best practices and lessons learned to support development/training of GMP auditors. Mentor junior GMP staff as required. Act as GMP compliance consultant for GMP trainings, task forces, continuous improvement projects as needed.
Ensur

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