Summary

About the role:
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.
Ensure alignment with strategic direction of the company and assist in driving implementation of the applicable actions. Provide consultation to Novartis business units through risk based assessments. Act as SME for assigned areas of responsibility.

• Support the strategic development of an effective global 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.
• Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures according to NVS requirements on Management Escalations and other relevant procedures. Ensure adequate definition and recording of mitigation plans when applicable.
• Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with the stakeholder QA representative and Auditee.
• Review and advise on relevant policies and procedures. Maintain current knowledge of regulations, standards, and guidance documents.

• At least 12 years broad experience in Pharmaceutical or Medical Device Industry. 3 years auditing experience preferred, and excellent knowledge of regulatory requirements. Sound and practical judgement in the interpretation and application of regulations and standards. Willingness to travel approximately 60% of the time.
• The operational experience should include QA/QC management and manufacturing, or development or other relevant experience e.g. working at a regulatory health authority. Experience and/or interaction with local Health Authority and sporadically with other Health Authorities.
• The operational experience should include QA/QC management and manufacturing, or development or other relevant experience e.g. working at a regulatory health authority.
• Expertise in at least one of the following areas: DP Manufacturing, Laboratories activities, Medical Devices, API, Biologics, Microbiology, Computer System Validation, Quality Systems, Cell&Gene therapy, Radioligand therapy, Sterile & Aseptice manufacturing.
• Strong interpersonal skills, including diplomacy and persuasion, used in obtaining cooperation and consensus with Novartis colleagues, vendors and customers. Ability to independently manage and objectively evaluate complex compliance issues with minimal supervision

• Excellent leadership and facilitation skills.
• Good team Player, collaborative