Mesoblast is a global, commercial-stage biotechnology company developing innovative cellular medicines for serious and life-threatening diseases. We're looking for an experienced Quality Assurance Manager to lead quality oversight of contract manufacturing operations and help us deliver our clinical and commercial cell therapy products from our Singapore hub.
If you thrive in a fast-moving GMP environment and enjoy working across international teams, contract manufacturers and regulators, this is your opportunity to help bring next-generation cell therapies to patients who need them.
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.
