Manager, R&D Quality
Core
Ensures quality assurance and compliance for oligonucleotide and xRNA research and development activities, supporting regulatory inspections and lifecycle initiatives.
Role type
Manager, R&D Quality (Oligonucleotide/xRNA)
Builds
Quality plans, regulatory files, and compliance strategies for oligonucleotide drug substances and products
Domain
Biopharmaceuticals / Oligonucleotide therapeutics
Required skills
Oligonucleotide modality expertise, GxP regulations, CMC development, Risk management, CAPA, Analytical method validation, Quality risk assessment
Preferred skills
xRNA platform approaches, Emerging regulatory expectations, Cross-functional collaboration
Technologies
IT systems, Analytical instruments, Manufacturing equipment
Responsibilities
Support maintenance of regulatory files for health authority inspections, Review oligonucleotide analytics including methods and stability, Aid in root cause investigations and CAPA development, Manage quality aspects of projects including third-party work and validations, Report technical complaints and adverse events
Seniority
Manager, hands-on leadership
