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Job ID 192045BR Position Title Global eCompliance ERP Functional Lead Division NBS Business Unit NBS QUALITY Country Switzerland Work Location Basel Company/Legal Entity Novartis International AG Functional Area Quality Job Type Full Time Employment Type Regular Job Description Lead the eCompliance activities for all GxP projects of the ERP IT function. Provide eCPL and quality support for all ERP IT GxP projects.
Ensure that the Novartis computer system validation (CSV) strategy is effectively implemented for all ERP IT GxP systems and that they remain compliant throughout their life-cycle.
Support the on-going implementation of data integrity controls within the respective IT systems landscape.
Support the development of compliance standards (e.g. Global Operating Proce-dures, templates, and training materials) as well as IT project related documents in line with Novartis quality and regulatory requirements in the respective IT function.
Ensure their implementation in the respective IT function. This includes operational lifecycle management documents of global GxP systems as well as relevant infra-structure.
1. Support the development and drive the implementation of the Novartis eCom-pliance strategy and one CSV process in line with the Novartis quality and regu-latory requirements within the ERP IT function to ensure effective and compliant quality oversight over Novartis GxP computerized systems.
2. Ensure the eCompliance strategy is fully integrated into the NBS ERP IT strate-gy.
3. Actively lead the eCompliance organization for the ERP IT function.
4. Develop and integrate appropriate risk based models for CSV activities of GxP systems within the ERP IT function.
5. Liaise effectively with NBS IT, all eCompliance personnel across NVS (e.g. manufacturing sites and countries), other Divisional quality and business functions to ensure that standards and effective processes for governing GxP computerized systems are in place, maintained and opportunities for continuous improvement identified and implemented.
6. Ensure integration of timely eCompliance reviews into the project lifecycle of IT systems in conjunction with the ERP IT function.
7. Ensure IT procedures and tools (e.g. ICE Methodology, IGM framework) accu-rately integrate and align with eCompliance and GxP related requirements.
8. Support implementation of all Data Integrity deliverables as defined by the PMO.
9. Support the development of and provide adequate quality input into all IT-related vendor selection, qualification and management processes and systems. Manage external contractors, as necessary.
10. Support in cooperation with Group GxP Training, the development and delivery of training relevant for Quality, IT and business functions in the area of com-puterized systems compliance.
11. Collaborate with Group Compliance and Auditing to monitor audit observations related to GxP computerized systems and computer system validation to ensure gaps are identified and adequately addressed. Minimum requirements Degree in Life Sciences, Pharmacy, Engineering or Information Technology; advanced degree preferred
Fluency in English (oral and written), additional language(s) a plus
• A minimum of 8 years of relevant experience in the Pharmaceutical Industry and in particular in regulated functions such as Quality and/or IT
• Profound understanding of global regulations and Health Authorities expectations governing com-puterized systems incl. computerized systems validation, lifecycle management and 21 CFR Par 11 requirements.
• Profound experience in the development, imple-mentation and lifecycle management of key computerized systems in the Pharmaceutical De-velopment, Manufacturing and Quality space (e.g. ERP/SAP, CTMS, MES, LIMS)
• Experience in project management of large global IT projects preferred
• Track record of successful cross-divisional/cross-functional work with complex international and multidisciplinary teams
• Proven ability to adjust to multiple demands, shifting priorities and unexpected events while maintaining a positive work attitude.
• Strong leadership presence, with ability to effec-tively interact with and present to Senior Man-agement