QA Manager, External Manufacturing (Cell Therapy)

Mesoblast Limited; New York (NY); Hybrid; USD 100,000 - 130,000; Full time

Benefits offered by this job

Annual STI bonus

Long-Term Incentive (LTI)

401(k) matching

Medical, dental and vision coverage

Additional company benefits

Job summary

Mesoblast Limited, a global biotechnology company, is seeking an experienced Quality Assurance Manager to provide quality oversight of external manufacturing activities for clinical and commercial cell therapy products in a hybrid New York setting.

This hands-on role involves QA oversight of CMOs, lot disposition, GMP documentation, investigations, CAPA, and regulatory compliance, collaborating with global Quality teams and partners to ensure cGMP/cGTP compliance and timely filings.

Qualifications

• Bachelor's degree in Life Sciences, Biotechnology, Pharmacy or related discipline.
• 6-8+ years of relevant experience in regulated life sciences with hands-on QA.
• Strong knowledge of GMP requirements and global regulatory expectations.
• Experience with quality systems, deviations, CAPAs, change controls and investigations.
• Experience working with CMOs or external manufacturing partners.
• Ability to manage multiple priorities and collaborate across internal and external teams.
• Experience supporting regulatory inspections or audits is advantageous.

Responsibilities

• Provide quality oversight of contract manufacturing partners ensuring cGMP/cGTP compliance.
• Support lot disposition and quality operations for commercial and clinical materials.
• Review and approve GMP documentation including batch records, SOPs, deviations, CAPAs and change controls.
• Maintain and improve quality systems that support manufacturing operations.
• Investigate quality issues, perform root-cause analysis and develop CAPA and risk-mitigation actions.
• Represent Quality during CMO inspections and participate in joint CMO project team meetings.
• Support regulatory filings through review of quality documentation.
• Provide quality input into risk assessments for raw materials and manufacturing processes.
• Prepare and communicate quality metrics, investigation outcomes, and project status to stakeholders.

Skills

Quality Assurance

GMP knowledge

Regulatory compliance

Problem solving

Cross-functional collaboration

Influencing stakeholders

Multitasking

Education

Bachelor's degree in Life Sciences

Job description

Mesoblast Limited, a global biotechnology company, is seeking an experienced Quality Assurance Manager to provide quality oversight of external manufacturing activities for clinical and commercial cell therapy products in a hybrid New York setting.

This hands-on role involves QA oversight of CMOs, lot disposition, GMP documentation, investigations, CAPA, and regulatory compliance, collaborating with global Quality teams and partners to ensure cGMP/cGTP compliance and timely filings.