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 systems with healthy ones, but also restore their lives.
The Senior Specialist, Global QMS will help implement Orca Bio’s global quality management system across all sites. This role will support and lead the internal audit program, supplier management program, and inspection readiness. This role will support the growth and expansion of the global quality program to support manufacturing of our cell therapy products. You will help establish, implement and maintain the audit program across Orca Bio sites to ensure compliance with GxP and regulatory expectations. Your role will support Orca Bios commercial readiness and ongoing clinical programs by managing and facilitating audits, resolving supplier-related quality issues and interacting with quality management teams at the site levels to ensure consistent application of quality systems across the organization.
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Responsibilities:
- Plan, schedule and execute internal audits across all sites and functions in accordance with the internal audit program.
- Develop audit agenda, conduct interviews, review processes and generate audit reports.
- Support the global Quality Management Review (QMR) process, ensuring timely data collection, analysis, and reporting to senior leadership.
- Support the supplier qualification and management program, including risk assessments, supplier audits, and ongoing monitoring to ensure compliance with GxP 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. MasterControl, ERP systems, Trackwise, etc.) ensuring alignment with regulatory and internal requirements.
- 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.
Experience:
- 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.
- Strong knowledge of global quality regulations and standards (FDA, EMA, ICH, ISO 9001, 21 CFR Parts 210/211/820, EU GMP).
- Proven experience leading Quality Management Review, internal audit programs, supplier management processes, and validation oversight.
- Demonstrated success in establishing and trending quality performance metrics and KPIs.
- Experience supporting and/or administering electronic QMS systems and partnering with IT for system enhancements.
- Experience working in a multi-site or