Quality Manager Digital Solutions TRD QA

Summary

Support global Data & Digital Initiatives (DDI) within Technical Research and Development (TRD) Quality Assurance by implementing digital solutions, in compliance with related quality systems ensuring regulatory compliance. This role reports to Quality Lead Data & Digital TRD QA and drives operational excellence by deploying and continuously improving GMP-compliant digital tools and processes. The position strengthens quality oversight, aligns with regulatory expectations, and enables cross-functional collaboration to support business transformation of TRD in data and digital space.

About The Role

Key Responsibilities :

• Implement and manage digital solutions for CMC (Chemistry Manufacturing Control) quality processes as directed by Quality Lead. Support the deployment and optimization of digital tools and systems that enhance quality processes and data integrity.
• Deploy AI / ML-based tools for process monitoring, deviation detection, and predictive analytics within CMC. Integrate manufacturing, laboratory, and quality data for comprehensive oversight and real-time decision-making.
• Lead validation, change control, and lifecycle management of digital GMP CMC systems to ensure GMP compliance. Oversee digitalization of CMC data management, documentation, and analytics (e.g., eBMR, eQMS, data lakes).
• Collaborate with IT, data science, manufacturing, regulatory, and global QA teams to align digital initiatives.
• Drive continuous improvement and automation in CMC quality processes. Contribute to GenAI and digital innovation initiatives by representing TRD QA in relevant forums and networks.
• Train and support end-users, fostering adoption and best practices in digital solutions.
• Monitor and report on quality metrics, identifying areas for improvement and driving corrective actions.
• Ensure documentation, audits, and inspections are managed effectively and in compliance with internal and external standards.

Minimum Requirements

Why Novartis

Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here : https : / / www.novartis.com / about / strategy / people-and-culture

You'll receive : You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https : / / www.novartis.com / careers / benefits-rewards

Commitment To Diversity And Inclusion

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

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 [HIDDEN TEXT] and let us know the nature of your request and your contact information. Please include the job requisition number in your message

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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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Skills Required

Gxp, Project Management, Data Science