Manager, R&D Quality

About the role

This role is based in Hyderabad, India. 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 stan

What you'll do

• 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

What you need

• Any graduate