eCompliance Manager

Job Description

Role Overview:As an eCompliance Manager at Novartis, you will be responsible for providing Quality Assurance oversight and guidance regarding computerized systems validation (CSV) while operating within the framework of regulations such as GxP, 21CFR11, and other relevant requirements outlined in the Novartis Quality Manual and global procedures.Key Responsibilities:- Oversight of operational activities of GxP systems including managing changes, periodic reviews, and deviations- Providing necessary support to ensure compliance with Novartis and regulatory requirements for GxP regulated computerized systems projects- Acting as the main point of contact for all CSV related matters for GxP Computerized Systems and bridging the gap between IT and Business for eCompliance issues in relation to GxP classified Computer Systems- Reviewing and approving project-related documents for GxP relevant systems, including determining GxP applicability for all systems- Establishing a trusted partnership with the IT Function, understanding business drivers, and providing day-to-day operational support- Reviewing and approving GxP changes and associated deliverables, as well as impacted deviations to ensure appropriate Corrective and Preventive Actions (CAPA) are implemented- Contributing to the preparation of Validation Master Plans (VMP) and executing the plan for systems associated with respective functions- Reviewing and approving Periodic Review Reports for GxP computerized systems and addressing any gaps within the CAPA Management System- Managing GxP supplier qualification activities and providing audit support as assignedQualification Required:- 10-15 years of overall IT experience with a minimum of 7 years in the Pharmaceutical Industry, particularly within regulated functions like IT Quality and Compliance- Strong understanding of global regulations and Health Authorities expectations governing computerized systems (CSV, Part 11, etc.)- Experience in the development, implementation, and lifecycle management of computerized systems in regulated environments- Familiarity with quality management of Cloud, Software as a Service (SaaS) platforms, mobile, and digital applications used in regulated environments- Proficiency in operational management of GxP solutions and related technologies to support operations- Good understanding of system application management, Quality support approach, and industry best practices (ITIL, ITSM, etc.)- Experience in the development, implementation, and lifecycle management of key computerized systems in Pharmaceutical Development, Manufacturing, Quality, Commercial, and Infrastructure space (e.g., ERP/SAP, MES, LIMS, CRM, IAM, etc.)Note: The job description includes key responsibilities and qualifications for the role of eCompliance Manager at Novartis, emphasizing the importance of ensuring compliance with regulations and quality standards in computerized systems validation. Role Overview:As an eCompliance Manager at Novartis, you will be responsible for providing Quality Assurance oversight and guidance regarding computerized systems validation (CSV) while operating within the framework of regulations such as GxP, 21CFR11, and other relevant requirements outlined in the Novartis Quality Manual and global procedures.Key Responsibilities:- Oversight of operational activities of GxP systems including managing changes, periodic reviews, and deviations- Providing necessary support to ensure compliance with Novartis and regulatory requirements for GxP regulated computerized systems projects- Acting as the main point of contact for all CSV related matters for GxP Computerized Systems and bridging the gap between IT and Business for eCompliance issues in relation to GxP classified Computer Systems- Reviewing and approving project-related documents for GxP relevant systems, including determining GxP applicability for all systems- Establishing a trusted partnership with the IT Function, understanding business drivers, and providing day-to-day operational support- Reviewing and approving GxP changes and associated deliverables, as well as impacted deviations to ensure appropriate Corrective and Preventive Actions (CAPA) are implemented- Contributing to the preparation of Validation Master Plans (VMP) and executing the plan for systems associated with respective functions- Reviewing and approving Periodic Review Reports for GxP computerized systems and addressing any gaps within the CAPA Management System- Managing GxP supplier qualification activities and providing audit support as assignedQualification Required:- 10-15 years of overall IT experience with a minimum of 7 years in the Pharmaceutical Industry, particularly within regulated functions like IT Quality and Compliance- Strong understanding of global regulations and Health Authorities expectations governing computerized systems (CSV, Part 11, etc.)- Experience in the development, implementation, and

Keyskills :
Quality AssuranceGxPRegulatory RequirementsComplianceCloudMobile ApplicationsOperational ManagementITILITSMMESLIMSCRMIAMComputerized Systems Validation21CFR11IT QualitySoftware as a Service SaaSDigital Applications