Senior QA Manager,Cell Therapy & Biologics | Hybrid NY

Mesoblast Limited; New York (NY); Hybride; USD 110 000 - 160 000; Plein temps

Résumé du poste

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.

Responsabilités

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

Connaissances

GMP knowledge

external manufacturing

auditing CMOs

quality investigations

regulatory inspections

Formation

Bachelor's in Life Sciences

Description du poste

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.