Job Description

28,000 associates of more than 100 nationalities deliver high quality and affordable medicine on time, every time, safely and efficiently. Your key responsibilities: Your responsibilities include, but not limited to: . 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. . 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. Act as GMP compliance consultant for GMP trainings, task forces, continuous improvement projects as needed. . Review and advise on relevant policies and procedures. Mentor junior GMP staff as required. Maintain current knowledge of regulations, standards, and guidance documents. Identify and report best practices and lessons learned to support development/training of GMP auditors. Diversity & Inclusion / EEO Minimum Requirements What you\'ll bring to the role: . Experience/ expertise in Low bioburden products/ Biotherapeutics/ Cell & Gene therapy/ x RNA technologies/ Radiopharmaceuticals is critical for the role. . 12 years broad experience in Pharmaceutical or Medical Device Industry. The operational experience should include QA/QC management and manufacturing, or development or other relevant experience e.g. working at a regulatory health authority. . 8 years GMP auditing experience preferred, and excellent knowledge of regulatory requirements. Willingness to travel approximately 60% of the time. . Expertise in at least one of the following areas: DP Manufacturing, Laboratories activities, Medical Devices, API, Excipients, Sterile, Biologics, Microbiology, Computer System Validation, Packaging activities, Quality Systems. . Experience and/or interaction with local Health Authority and sporadically with other Health Authorities. Strong interpersonal skills, including diplomacy and persuasion, used in obtaining cooperation and consensus with Novartis colleagues, vendors and customers. . Sound and practical judgement in the interpretation and application of regulations and standards. Ability to independently manage and objectively evaluate complex compliance issues with minimal supervision. Excellent leadership and facilitation skills Desirable: . Degree in Chemistry, Pharmacy, Biology, Engineering or another related science. Advanced degree preferred. Other degrees with relevant experience may be accepted . Excellent oral and written English communication skills. Preferable: Good knowledge/mother tongue of an additional language (e.g. German, French, Italian, Chinese, or Spanish) is preferred. Why Novartis 236 million lives were touched by Novartis medicines in 2021, and while we\'re proud of this, we know there is so much more we could do to help improve and extend people\'s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what\'s possible, when we collaborate with courage to aggressively and ambitiously tackle the world\'s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis! Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to and let us know the nature of your request and your contact information. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:

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