R&D Senior Quality Manager Data & Digital

Band

Level 4

 

Job Description Summary

The Senior Quality Manager Data & Digital Technical Research & Development (TRD) Quality Assurance (QA) oversees the incorporation of new technologies in TRD and the implementation of digitalization strategies in business processes.

The role incumbent reports into the TRD QA platform and represents QA in the respective modality. They are a direct member of the TRD QA Data & Digital (D&D) Network and the TRD digital Chemical Manufacturing Control (CMC) accelerator team. They oversee the function specific D&D portfolio and, act as global business process owner for Biologics (Bx)/Cell & Gene Therapies (CGT) QA in Spine and Strive. They drive global digital projects and also, provide quality assurance expertise, guidance and support to operational activities in development and research organizations to ensure compliance with applicable regulatory requirements and Novartis procedures and quality standards. They will manage projects, including Quality Plan initiatives, and processes that support quality objectives to assure their compliance with Good Practice (GxP) regulations.  

 

Job Description

Major accountabilities:

Represents the TRD QA Bx platform in the TRD QA Data & Digital Network 

• Acts as GPO (Global Process Owner) for QA in the own QA platform. Is QA member of the digital CMC accelerator team (Strive and SPINE). Drives cross-platform alignment. 
• Owns and drives the Data & Digital portfolio for QA as partner of the respective TRD functions (close partnership with the line function Specialist Point of Contact (LF SPOCs) in TRD). Ensures the LF portfolio is covered within the global TRD QA Data & Digital portfolio. 
• Is accountable for QA oversight during project execution in function specific and x-functional projects. Supports the global platform head and the TRD QA data & digital network lead to ensure appropriate staffing of respective improvement projects. 
• Ensures that Data & Digital projects / tools impacting TRD and/or TRD QA are well supported during ideation, execution and implementation phases. Takes accountability for driving Good Manufacturing Practice (GMP) compliant change control execution and ensures close partnership with the respective e-compliance teams. 
• Ensures direct and close communication within the own TRD QA platform and to other TRD QA platforms. 

 

Leads complex global Data & Digital projects directly or contributes as TRD QA representative. 

• Is a member of global TRD and/or Research & Development Quality (RDQ) Data & Digital Projects as TRD QA SPOC. 
• Has a solid understanding of the respective GMP business process and ensures end to end (E2E) oversight of the data flow. Is accountable for QA oversight of the business process changes including potential QMS updates. 
• Holds the team accountable for GMP compliant change control execution. 
• For complex projects with more than one TRD QA member: Leads the TRD QA subteam and ensures “one voice” decision making.   

Contributes to the TRD QA own Data & Digital agenda including organizational upskilling 

• Fosters Artificial Intelligence (AI) usage in TRD QA, acts as an ambassador for the TRD digitalization journey and the extended use of AI tools in TRD in a GMP compliant manner. 
• Being part of TRD QA D&D Exchange Network and participate TRD QA D&D Review Board and supports TRD QA D&D portfolio oversight management (Mission control). 
• Contributes to the know-how exchange with external partners to strongly support the Novartis digital and AI journey (RDQ Gen AI network).  
• Develops individual quality know-how to enable extended use of AI tools in TRD in a GMP compliant manner. Provides functional expertise to part-time members within the TRD D&D QA platform. 
• Proposes and owns digital projects to improve ways-of-working in TRD GMP areas and within TRD QA. 
• Support maintenance of the regulatory-required files for health authority inspections and assist with health authority inspection management
• Support generation of Quality Plans (and review other plans for quality/safety aspects)
• Aid in the identification of quality issues and assist with root cause investigations and Support the development of corrective and preventative action plans (CAPA), including monitoring status to Ensure issues are addressed,