Quality Assurance Manager

Mesoblast Limited; New York (NY); On-site; USD 110,000 - 160,000; Full time

Job summary

Mesoblast seeks a Quality Assurance Manager to oversee external manufacturing compliance and quality operations for its cell therapy products, supporting clinical and commercial supply chains.

The role involves auditing CMOs, reviewing GMP documentation, managing lot disposition, investigating quality issues, and participating in regulatory inspections and quality systems improvements. Hybrid in New York with up to four days onsite and one day remote.

Qualifications

• Bachelor’s in Life Sciences or related field.
• 6–8+ years of QA experience in regulated biopharma with strong GMP knowledge.
• Experience working with external manufacturing partners.

Responsibilities

• Audit contract manufacturing organizations (CMOs).
• Review GMP documentation.
• Manage lot disposition.
• Investigate quality issues.
• Participate in regulatory inspections and quality systems improvement.

Skills

GMP knowledge

external manufacturing

auditing CMOs

quality investigations

regulatory inspections

Education

Bachelor's in Life Sciences

Job description

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

• auditing contract manufacturing organizations (CMOs)
• reviewing GMP documentation
• managing lot disposition
• investigating quality issues
• 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.