Summary

Location: HYD, India

This role is based in Hyderabad, India. Novartis is unable to offer relocation support for this role. Please only apply if this location is accessible for you.

The Manager, R&D; Quality provides quality assurance expertise and oversight for research and development activities, with a particular focus on oligonucleotide and xRNA analytics. The role partners with cross-functional teams to ensure compliance with applicable GxP regulations, regulatory requirements, Novartis procedures and quality standards.

About The Role

Major Accountabilities:

• 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) for clinical programs
• Support review of Oligonucleotide Analytics, including analytical methods, stability, control strategies, impurities, and quality risk assessment.
• Support cross functional CMC, regulatory,



and lifecycle initiatives for oligonucleotide drug substances and drug products.
• Support initiatives to maintain or improve quality performance and compliance of operational activities including risk management, health authority reporting, IT systems
• Support initiatives focused on quality, process and compliance improvement, including identification of opportunities and develop strategies aimed at improving quality while ensuring compliance with regulatory requirements
• Ensure information gained during quality and compliance initiatives, as well as audit and assessment results, are evaluated to identify any regulatory, compliance and QA training needs
• 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, completed and documented.
• Provide assistance in the remediation of deviati

📌 Manager, R&D Quality (Hyderabad)
🏢 Novartis India
📍 Hyderabad