Quality Assurance Manager

Role: The Quality Assurance Manager oversees external manufacturing compliance and quality operations for Mesoblast’s cell therapy products, supporting clinical and commercial supply chains. Responsibilities include auditing contract manufacturing organizations (CMOs), reviewing GMP documentation, managing lot disposition, investigating quality issues, and participating in regulatory inspections and quality systems improvement. Requirements: Bachelor’s in Life Sciences or related field; 6–8+ years of QA experience in regulated biopharma, with strong GMP knowledge and experience working with external manufacturing partners. Preferred: experience in biologics, cell therapy, or sterile manufacturing; regulatory inspection support. High-Value: Cell therapy modalities, biologics manufacturing, GMP compliance, CMO oversight, quality investigations, regulatory documentation review. Work setup: Hybrid in New York; up to four days onsite, one day remote.