Job Description

### Summary

The System Support and Integration Manager (SSIM) is responsible to configure IT applications and design processes in the applications to support business processes for Analytics within TRD. The SSIM plays a key role in the implementation and integration of strategic projects ensuring full integration with all other functions in TRD where necessary. The SSIM analyses business needs and configures systems to address unmet needs. The SSIM is responsible to ensure that the processes and configuration are working in an integrated GxP environment and are in line with the TRD system and data strategy. The SSIM is accountable to determine business needs for improvement process initiatives, assesses new technologies, design digital approaches and methodology, analyze organizational data to recommend solutions to new and complex problems, adopt data driven approaches in decision-making and build new business models. The SSIM has operational end to end responsibility for assigned systems and leads and manages all local and global project activities and participates in cross-functional teams.
### About the Role


Your responsibilities include, but are not limited to:



• As being an expert in the system configuration of key applications (e.g. Labware LIMS), conduct gap assessment and define system design and configuration to improve end user satisfaction.
• Create and manage system configuration static master data in key applications. Drive standardization and normalization of global/organization/site static master data.
• Liaise with system and process owners and actively contribute and participate in the system governance and change advisory board.
• Assess risk, conduct RCA and perform impact assessments for changes and problems; As project development lead (workstream lead), own and drive change to key applications in close collaboration with line functions and IT.
• Establish and own URS and be responsible for informal and formal testing and validation UAT / OQ / PQ. Ensure adherence to standards and compliance of processes with regulations as well as Novartis internal procedures and GxP requirements.
• Understand the supported business processes and interfaces of key applications. Identify, align & facilitate global harmonization opportunities across TRD. Collaborate with business process experts to understand, challenge, and incorporate business processes into key applications.
• Contribute to the life-cycle management of key applications. Facilitate the collaboration between Dev IT and Line Functions and external partners for system/application improvement and enhancement projects
• As a subject matter expert or recognized technical expert, provide guidance, training and education to users, super users and team members on usage and best practices in key applications. Act as mentor or coach for junior and senior associates.

Role Requirements :

• 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. Labware LIMS, Chromeleon, 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
• Technician or Bachelor/Master in Life Science or Information technology (e.g., analytical / organic chemistry / pharmacy / pharmaceutical development, IT) or equivalent.
• Advanced degree in science of relevant discipline (Ph.D., MSc or equivalent). Familiar with existing IT tools (e.g. Labware LIMS, Chromeleon, SAP) and strong interest in new digital tools.


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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Division
Development
Business Unit
Innovative Medicines
Location
India
Site
Hyderabad (Office)
Company / Legal Entity
IN10 (FCRS = IN010) Novartis Healthcare Private Limited
Functional Area
Data Science
Job Type
Full time
Employment Type
Regular
Shift Work
No


Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.