Global QA Manager, Cell Therapy & cGMP

mesoblast limited; Singapore; On-site; SGD 180,000 - 240,000; Full time

Job summary

Mesoblast Limited is seeking a seasoned Quality Assurance leader to ensure cGMP/compliance across our Singapore operations. You will oversee contract manufacturers, approvals of GMP documentation, and drive quality excellence with global partners.

Reporting to global Quality leadership, you will lead investigations, CAPA, risk mitigation, and support regulatory filings, audits, and inspections, shaping a resilient quality system and ensuring patients receive safe, high-quality cell therapy

Qualifications

• Bachelor's degree in Life Sciences, Biotechnology, Pharmacy or related discipline.
• 8+ years of experience in Quality Assurance within pharmaceutical, biologics, cell therapy or other regulated environments.
• Strong knowledge of GMP requirements and global regulatory expectations (HSA, FDA, EU GMP, TGA, PIC/S).
• Experience managing deviations, change controls, CAPAs and investigations.
• Experience working with CMOs and external manufacturing partners.
• Nice to have: experience in biologics, advanced therapies, cell therapy or sterile manufacturing, and involvement in regulatory inspections and audits.

Responsibilities

• Manage quality of products manufactured by contract manufacturing partners to ensure cGMP/cGTP compliance.
• Support lot disposition and batch release for commercial products and clinical trial material.
• Review and approve GMP documentation including batch records, SOPs, deviations, and change controls.
• Maintain and improve quality systems supporting Singapore operations.
• Lead investigations, root-cause analyses, CAPA activities, and risk mitigation.
• Represent Quality at CMO inspections and participate in joint project team meetings.
• Drive quality and regulatory compliance initiatives addressing GMP issues and operational requirements.
• Support regulatory filings and contribute to risk assessments across materials and processes.
• Report quality metrics and project status to internal and external stakeholders.

Skills

Quality Assurance

cGMP knowledge

Regulatory knowledge

CMO collaboration

Education

Bachelor's degree in Life Sciences/Biology/Related

Job description

Mesoblast Limited is seeking a seasoned Quality Assurance leader to ensure cGMP/compliance across our Singapore operations. You will oversee contract manufacturers, approvals of GMP documentation, and drive quality excellence with global partners.

Reporting to global Quality leadership, you will lead investigations, CAPA, risk mitigation, and support regulatory filings, audits, and inspections, shaping a resilient quality system and ensuring patients receive safe, high-quality cell therapy