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Orca Bio is a commercial-stage biotechnology company developing next-generation cell therapies to improve outcomes for patients with blood cancer. The company is redefining the transplant process with purified, high-precision cell therapies designed to replace patients' blood and immune systems while minimizing risks like graft-versus-host disease.
As Senior Specialist, Global QMS, you will be instrumental in implementing and maintaining Orca Bio's quality management system across all manufacturing and operational sites. This role sits at the intersection of regulatory compliance, operational excellence, and organizational growth.
Key responsibilities include:
- Establishing, implementing, and maintaining a comprehensive internal audit program across Orca Bio sites to ensure compliance with GxP (Good Practice) regulations and regulatory expectations
- Leading and managing the supplier management program, including supplier qualification, oversight, and resolution of quality-related issues
- Supporting inspection readiness initiatives to prepare sites for regulatory inspections and audits
- Facilitating audits and quality assessments across multiple sites
- Collaborating with quality management teams at site levels to ensure consistent application of quality systems organization-wide
- Supporting the company's commercial readiness and ongoing clinical programs through robust quality oversight
You will drive the growth and expansion of the global quality program as Orca Bio scales manufacturing of its cell therapy products. This is a strategic role that requires both deep quality systems expertise and the ability to influence and align cross-functional teams across geographically distributed sites.
