Senior Specialist Global QMS

About the role

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision cell therapies we hope to not only replace patients' blood and immune s

Requirements

• Drive global inspection management activities, ensuring cross-functional and site readiness for FDA, EMA, and other health authority inspections.
• Provide oversight and guidance to site QMR administrators ensuring consistent quality system implementation across all Orca Bio sites.
• Establish and monitor global QMS key performance indicators (KPIs), oversee trending of quality metrics, and ensure data-driven insights are used to improve quality systems and performance.
• Partner with IT and business process owners to identify and implement QMS system enhancements, including defining requirements, driving prioritization and ensuring changes are validated and compliant.
• Review, approve, and provide quality oversight for validation documentation (e.g., equipment qualification, computer system validation, process validation) for global enterprise systems (e.g. MasterCo
• Collaborate with cross-functional and site leadership teams to drive continuous improvement initiatives, ensuring the QMS evolves in line with business needs and regulatory expectations.
• Bachelor’s degree in a scientific or engineering discipline required; advanced degree preferred.
• Minimum 5+ years of relevant Quality Assurance or Quality Systems experience in a GxP-regulated environment, with at least 2-3 years in a leadership role.