Quality Assurance Manager

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 is a global, commercial-stage biotechnology company developing innovative cellular medicines for serious and life‑threatening diseases.

We are looking for an experienced Quality Assurance Manager to provide quality oversight of our external manufacturing operations and support the delivery of clinical and commercial cell therapy products.

This is a hands‑on individual contributor role with no direct reports. You will work closely with global Quality colleagues, internal stakeholders and external manufacturing partners, using your QA expertise to support GMP compliance and effective quality operations.

If you thrive in a fast‑moving GMP environment and enjoy working across international teams and contract manufacturing partners, this is an opportunity to contribute directly to bringing innovative cell therapies to patients.

You will provide quality oversight of contract manufacturing activities, helping ensure our manufacturing partners operate in accordance with cGMP/cGTP requirements.

Working across internal and external teams, you will support quality systems, lot disposition, GMP documentation, investigations, CAPA, regulatory compliance and continuous improvement. Applications close Thursday October 8, 2026. This role follows a hybrid working model, with up to four days per week based in our New York office and one day working from home.

What You'll Do

• Provide quality oversight of products manufactured by our contract manufacturing partners, supporting compliance with cGMP/cGTP requirements.
• Support lot disposition and quality operations for commercial products and clinical trial material.
• Review and approve GMP documentation, including batch records, SOPs, deviations, CAPAs and change controls.
• Maintain and continuously improve quality systems supporting manufacturing operations.
• Investigate quality issues, perform root‑cause analysis and develop appropriate CAPA and risk‑mitigation actions.
• Represent Quality during CMO inspections and participate in joint CMO project team meetings.
• Participate in quality and regulatory compliance initiatives addressing GMP issues and operational requirements.
• Support regulatory filings through review of relevant quality documentation.
• Provide quality input into risk assessments relating to raw materials and manufacturing processes.
• Prepare and communicate quality metrics, investigation outcomes and project status to internal and external stakeholders.

What You'll Bring

• Bachelor's degree in Life Sciences, Biotechnology, Pharmacy or a related discipline.
• Typically 6-8+ years of relevant experience within pharmaceutical, biotechnology, biologics or another highly regulated life‑sciences environment, with demonstrated hands‑on Quality Assurance experience.
• Strong knowledge of GMP requirements and relevant global regulatory expectations.
• Demonstrated experience working with quality systems, deviations, CAPAs, change controls and investigations.
• Experience working with CMOs or external manufacturing partners.
• Strong problem‑solving skills with the ability to manage multiple priorities and work effectively across internal and external teams.
• Ability to build effective relationships and influence stakeholders without direct reporting authority.
• Experience in biologics, cell therapy, advanced therapies or sterile manufacturing would be highly regarded.
• Experience supporting regulatory inspections or audits would be advantageous.

Why Mesoblast?

• Work at the forefront of cellular medicine, supporting therapies with the potential to make a meaningful difference to patients with serious and life‑threatening diseases.
• Gain exposure to global manufacturing and quality operations within a commercial‑stage biotechnology company.
• Work closely with experienced Quality professionals, external manufacturing partners and cross‑functional teams.
• Join a collaborative, close‑knit environment where your expertise and contribution are visible.
• Build broad experience across commercial and clinical manufacturing, quality systems, regulatory compliance and CMO oversight.

The anticipated base salary range for this position is $100,000-$130,000 USD per year. Actual base salary will be determined based on relevant experience, qualifications, skills and other job‑related factors.

In addition to base salary, Mesoblast offers a competitive total rewards package which may include:

• Annual Short‑Term Incentive (STI) bonus opportunity
• Long‑Term Incentive (LTI) participation, subject to eligibility and applicable plan terms
• 401(k) retirement plan with company matching
• Medical, dental and vision coverage
• Additional company benefits and leave programs in accordance with applicable Mesoblast policies and plan terms

Agency Notice

Mesoblast works with an established Preferred Supplier List (PSL). Unsolicited agency applications or candidate submissions will not be accepted for this position.