Quality Assurance Manager
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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.
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