Ecompliance Manager

Summary The eCompliance Manager is responsible for providing Quality Assurance oversight and guidance with regard to computerized systems validation CSV operating within the framework of regulations GxP 21CFR11 etc and requirements defined in the Novartis Quality Manual and global procedures eCompliance Manager provides the needed operational support such as approving the GxP impacted changes Periodic Review Reports deviations etc Provides the guidance to the project and operations team on the CSV related topics and related information Reviews and or approves the global Computerized Systems key validation deliverables as a part of the eCompliance support to the GxP projects Major accountabilities 1 Quality oversight of operational activities of GxP systems e g Changes Periodic Reviews Deviations etc 2 Provide needed support to meet the applicable Novartis and regulatory requirements for GxP regulated computerized systems projects 3 Point of Contact for all CSV related matters for GxP Computerized Systems and act as an interface between IT and Business for eCompliance topics in relation to GxP classified Computer Systems promoting a Quality Culture 4 Review and approve project related documents for GxP relevant systems including determination of GxP applicability for all GxP and non-GxP relevant systems 5 Establish trusted partnership with assigned IT Function with understanding of business drivers and provide the needed day to day operational support 6 Review and approve the GxP Changes and the associated deliverables 7 Review and approve the GxP impacted deviations ensure appropriate CAPA are implemented 8 Contribute for the preparation of VMP and execute the plan for the systems associated with the respective functions 9 Review and approve the Periodic Review Reports for the GxP computerized systems and the associated gaps within CAPA Management System 10 Perform supplier qualification assessment activities 11 Provide Audit support as assigned and in case of CAPAs provide the required Quality support Key performance indicators 1 GxP relevant computerized systems are developed implemented and maintained according to the Novartis requirements 2 On time review and approval of changes deviations periodic review reports for the GxP computerized systems 2 Documentation supporting eCompliance and CSV requirements is in place maintained up-to-date and can be presented during audits and inspections without delays and issues 3 Gaps in eCompliance and CSV activities are proactively identified escalated and the development of mitigation plans supported 4 Client stakeholder satisfaction and corresponding feedback Minimum Requirements Work Experience 10-15 years of overall IT experience and a minimum 7 years of relevant experience in the Pharmaceutical Industry and in particular within regulated functions such as IT Quality and Compliance Skills Solid understanding of global regulations and Health Authorities expectations governing computerized systems CSV Part 11 etc Solid experience in the development implementation and lifecycle management of computerized systems in regulated environments Experience in quality management of Cloud SaaS platform mobile and digital application used in regulated environments Highly experienced in the operational management of GxP solutions including its related technologies to support the operation Good understanding in system application management its Quality support approach and industry best practices ITIL ITSM etc Experience in the development implementation and lifecycle management of key computerized systems in the Pharmaceutical Development Manufacturing Quality Commercial and Infrastructure space e g ERP SAP MES LIMS CRM IAM etc Successful cross-divisional functional work with complex international teams Experience in GxP supplier qualification activities Proven ability to adjust to multiple demands shifting priorities and unexpected events while maintaining a positive work attitude Ability to effectively interact and present to Management Ability to manage the key stakeholders and build trust Proven ability to influence without hierarchical authority and build trusted partnerships Proven self-starter with experience in initiating and delivering projects and processes Excellent communication negotiation facilitation and interpersonal skills Languages English Why Novartis Our 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 https www novartis com about strategy people-and-culture You ll receive You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook https www novartis com careers benefits-rewards Commitment to Diversity and Inclusion Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve 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 https talentnetwork novartis com network Skills Desired Auditing Audit Management Communication Skills Compliance Audits Compliance Risk Continued Learning Dealing With Ambiguity Decision Making Skills Gmp Procedures Inspection Readiness Organizational Skills People Management and Leadership Qa Quality Assurance Regulatory Compliance Risk Management Self-Awareness Technological Expertise