Job Description

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.

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:

• 10 years in pharmaceutical quality, with at least 2-5 years in digital solutions implementation or management within CMC or related areas.
• Hands-on experience with validation, deployment, and lifecycle management of digital tools in a regulated (GMP) environment.
• Proven track record leading digital projects, supporting global and cross-functional teams.
• Experience with audits, inspections, and maintaining compliance of digital CMC systems. Technical expertise in digital CMC platforms, data science, and AI/ML applications in pharma.
• Strong project management and digital tool deployment capability. Strong understanding of Software development Life Cycle (SDLC)
• Understanding of chemical manufacturing processes, Laboratory practices etc. Deep knowledge of GxP, QMS, CSV, and regulatory compliance for CMC systems.

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 diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
https://talentnetwork.novartis.com/network
Skills Desired Agility, Analytical Development, Auditing, Audit Management, Business Partnering, Change Control, Continued Learning, Health Authorities, Influencing Skills, Knowledge Of Capa, Qa (Quality Assurance), Quality Management, Risk Management, Root Cause Analysis (RCA), Self-Awareness, Six Sigma, Sop (Standard Operating Procedure), Technological Expertise

Skills Required