Summary

About the role:

Responsible for managing quality aspects at external suppliers for pharmaceutical products and to ensure that the operational business is in compliance with cGMP, the Quality Assurance Agreement, regulatory requirements, and the Novartis Pharma Quality Manual and is conducted according to the relevant SOPs

About The Role

Key Requirements:

• Lead External Suppliers Qualification process. Acts as Single Point of Contact / SPOC for all quality related activities at the External Supplier. Ensure that all aspects of the handling, manufacturing and distribution of pharmaceutical products are in compliance with the Novartis Pharma Quality Manual, the effective Quality Agreement that they meet relevant cGMP regulatory requirements and are conducted according to local SOPs
• Provide quality leadership and oversight for technology transfer activities involving external suppliers, ensuring successful transfer of products, processes, analytical methods, specifications, and relevant documentation in compliance with Novartis Quality Standards, Quality Agreements,



and regulatory expectations.
• Review and approve technology transfer protocols, risk assessments, validation strategies, comparability evaluations, and transfer reports, ensuring readiness for commercial manufacturing and supply. Responsible for driving / initiating External Supplier Quality Risk assessments for all External Suppliers. Gaps in Quality Systems to be identified with an evaluation of the associated risks. Remediation plans are to be defined and execution is to be monitored to ensure that issues are suitably addressed.
• Provide the quality presence and in-put to technical meetings with the External suppliers and establish good working relationships with transparent communication and defined actions and goals. Responsible for coordinating and ensuring that Quality auditing of External suppliers is carried out according to the Novartis Quality Manual - maintain an annual auditing progr

📌 Manager, Quality Assurance (India)
🏢 Novartis India
📍 India