ph3Summary /h3 pIn 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 General 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. /p h3About The Role /h3 pIn this role you will be required to travel up to 60% of time. /p h3Major Accountabilities /h3 ul liSupport the strategic development of an effective global risk-based audit strategy and program. Collect, collate, and incorporate input into the audit strategy and plan. /li liPlan, 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. /li liFor 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. /li liProvide regulatory guidance for timely remediation and recommendations regarding acceptability of the proposed filing.



/li liPrepare 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. /li liEnsure 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. /li liAssess the adequacy of responses (CAPA plans) to audit findings in cooperation with the stakeholder QA representative and Auditee. /li liReview and advise on relevant policies and procedures. Maintain current knowledge of regulations, standards, and guidance documents. /li /ul h3Essential Requirements /h3 ul li12+ years broad experience in Pharmaceutical or Medical Device Industry. 3 years auditing experience preferred, and excellent knowledge of regulatory requirements. /li liStrong knowledge of GMP regulations, sound and practical judgement in the interpretation and application of regulations and standards. /li liSolid operational experience, that should include QA/QC management and manufacturing, development or other relevant experience e.g.



working at a regulatory health authority. /li liStrong experience in Sterile and/or expertise in at least one of the following areas: DP Manufacturing, Laboratories activities, Medical Devices, API, Biologics, Microbiology, Computer System Validation, Quality Systems, CellGene therapy, Radioligand therapy. /li liStrong interpersonal skills, including diplomacy and persuasion, used in obtaining cooperation and consensus with Novartis colleagues, vendors and customers. /li liAbility to independently manage and objectively evaluate complex compliance issues with minimal supervision. /li liFluent English, written and spoken. Other languages are a plus. /li /ul h3Desirable Requirements /h3 ul liExperience and/or interaction with local Health Authority and sporadically with other Health Authorities is a plus. /li /ul h3Why Novartis? /h3 pOur purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: /p h3You’ll receive /h3 pYou can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. /p h3Benefits and rewards /h3 pRead our handbook to learn about all the ways we’ll help you thrive personally and professionally: /p h3Commitment To Diversity And Inclusion /h3 pNovartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. /p /p #J-18808-Ljbffr

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