Zusammenfassung
The BSO is responsible for establishing and conducting oversight on system and data usage, controls all changes, ensures proper governance and compliance of the system and has operational responsibility end to end.
Responsibilities include stakeholder analysis, establishing ongoing relationships with key stakeholders and decision makers, representing the user organization, being available for input and review of project deliverables, participating in prototyping exercises and in user acceptance testing
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.
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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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
