Quality Assurance Manager

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

The Role

Reporting to global Quality leadership based in the US, you'll ensure our contract manufacturers meet cGMP/cGTP requirements, review and approve GMP documentation, and partner with internal and external stakeholders to release high-quality cell therapy products to patients. You'll maintain quality systems, lead investigations and CAPA, and drive quality excellence across our Singapore operations.

What You'll Do

• Manage the quality of product manufactured by our contract manufacturing partners, ensuring 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 continuously improve the quality systems supporting our Singapore operations.
• Lead investigations and root-cause analyses, drive CAPA activities, and develop risk mitigation plans.
• Represent Quality at CMO inspections and participate in joint CMO project team meetings.
• Lead quality and regulatory compliance initiatives addressing GMP issues and operational requirements.
• Support regulatory filings and contribute quality input to risk assessments across raw materials and manufacturing processes.
• Report on quality metrics, investigations and project status to internal and external stakeholders.

What You'll Bring

• A Bachelor's degree in Life Sciences, Biotechnology, Pharmacy or a related discipline.
• 8+ years' experience in Quality Assurance within pharmaceutical, biologics, biotechnology, cell therapy or another regulated environment.
• Strong knowledge of GMP requirements and global regulatory expectations, including HSA, FDA, EU GMP, TGA and PIC/S standards.
• Experience managing deviations, change controls, CAPAs and investigations.
• Experience working with CMOs and external manufacturing partners.
• A plus: experience in biologics, advanced therapies, cell therapy or sterile manufacturing, plus prior involvement in regulatory inspections and audits.

Why Mesoblast?

• Work at the forefront of regenerative medicine, on therapies with the potential to change patients' lives.
• Exposure to global manufacturing and quality operations across a growing international pipeline.
• A collaborative, close-knit team where your work has visible, direct impact.

We regretfully advise that we already have a PSL (Preferred Supplier List) framework in place, and unsolicited agency submissions will not be accepted for this role.