Senior eCompliance Program Manager

Senior eCompliance Program Manager

Location – Hyderabad #LI Hybrid

About the Role:

The Senior eCompliance Program Manager is a strategic leadership role responsible for co-developing, operationalizing, and governing an enterprise-wide framework for the use of AI in GxP environments, including Quality Assurance (QA) oversight of regulated and non‑regulated IT systems. This position goes significantly beyond the remit of a classical senior e‑Compliance manager, combining deep compliance expertise with enterprise‑scale program leadership, change stewardship, and cross‑functional orchestration.
Drawing from the competencies outlined for global program management roles—such as proactive leadership, structured program oversight, cross-functional influence, and the ability to lead across complex, high‑pressure circumstances—and the eCompliance responsibilities associated with CSV, regulatory frameworks, and quality oversight, this role is designed for an advanced leader capable of shaping global digital quality strategy

Key Responsibilities:

• Successful coordination with key stakeholders outside of eCompliance, across Novartis business units to implement the QA oversight program/GxP framework for AI
• Successful support of projects with agreed quality & delivery dates, passing of internal and external inspections. Meet quality and timelines for all projects.
• Act in accordance with Novartis standards. The number and severity of cGMP issues identified during internal & external audits.
• Successful coordination of departmental operational activities.
• Oversight and implementation of Quality Management System
• Responsible for GxP Audit and inspection management.
• Responsible for  Site Regulatory oversight (incl. Reg -CMC facilitation).
• Responsible for Supplier Quality management (local) Qualification and validation.

Commitment to Diversity & Inclusion:

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

Essential Requirements

• Minimum 10 years’ experience in co-developing, operationalizing, and governing an enterprise-wide framework for the use of AI in GxP environments, including Quality Assurance (QA) oversight of regulated and non‑regulated IT systems.
• Minimum/Desirable: Degree in Life Sciences, Pharmacy, Engineering or Information Technology. An advanced degree is preferred.

Desirable Requirements

• Strong cross-functional skills and proven experience in collaboration with other departments/groups.
• Excellent interpersonal communication and presentations skills
• Demonstrated innovative thinking and solution-oriented problem solving skills.
• Ability to manage work output within given timelines.
• Complex program management skills.
• Good Manufacturing Practices (cGMP).

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.
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.