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eCompliance Manager
Banking Financial Services
💰 Salary Not shared
📊 Market 180,000 CHF–280,000 CHF/mo (2,160,000 CHF–3,360,000 CHF/yr)
About the Company
Job Description Summary About the role: 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. Job Description Key Requirements: Quality oversight of operational activities of GxP systems (e.g., Changes, Periodic Reviews, Deviations etc.,) Drive the design, deployment and continuous improvement of automation and AI-enabled solutions within assigned processes. Provide needed support to meet the applicable Novartis and regulatory requirements for GxP regulated computerized systems projects. Supports the development of future-focused strategy in AI and emerging technologies readiness, evaluating regulatory requirements and developments to ensure Novartis QMS is fit for purpose in the eCompliance environment. Point of Contact for all CSV related matters for GxP Computerized Systems and act as an interface between IT and Busines
Requirements
- ● Degree in Information Technology, Life Sciences, Pharmacy, Engineering or equivalent
- ● 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
- ● 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
- ● 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.)
- ● Successful cross-divisional/functional work with complex international teams
- ● 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
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