About the Role
- Accountable for establishing and maintaining the operational (validated for GxP systems) state of a computerized system, in accordance with existing SOPs.
- Ensure that SOPs and other documents required for the operation and maintenance of the system are prepared, updated, approved and followed.
- Act as System Governance Lead with real ownership for the concerned system and definition of future strategy in close alignment with TRD LFs and Development IT (IT counterpart is the Application Manager), leading the System Governance and Change Advisory Board.
- Knowledgeable about relevant business processes and the system supporting it. Define expected business outcomes that are supported by the application.
- Description and clarification of business workflows and terminology to help the IT organization understand the business requirements of the application.
- Identification of criticality of selected functions and data to ensure business process is enabled.
- Represent the application in business strategy discussions and ensure short- and long-term strategy is in place for the application.
- Control and prioritize all business requirements and change requests that are submitted to IT, ensuring operational/ validated state of the system with efficient use of available resources and budget.
- Support prioritization of budget spends, SLA and compliant retirement of application.
- Support and foster spirit of an inspired, curious and agile learning organization, including best practice sharing across digitalization projects.
- Acts as role model for Novartis values and behaviors
Experience /Professional requirement
- Knowledge in quality principles driving drug development such as GMP; understanding of general regulatory and quality expectations.
- Strong communication skills, including presentation and scientific/ technical writing. Advanced coaching skills.
- Minimum 3 years in relevant position in a GMP environment.
- Sound technical and regulatory knowledge. Working knowledge in pharmaceutical research and technical development.
- Experienced in GMP environment, with familiarity of IT systems (e.g. eLN, GLIMS, SAP), and interfaces between different data tools.
- Comprehensive knowledge about project management, excellent organization and planning skills.
- Experience in upgrading existing IT tools into the mobile IT world (smart phones, tablets).
- Proven track record in successfully leading and working in interdisciplinary teams.
- Strong innovation mindset and problem solving skills.
Role Requirements
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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