Senior Specialist Global QMS

About the role

The Senior Specialist, Global QMS will help implement and maintain Orca Bio's global quality management system across all sites. This role supports the internal audit program, supplier management, and inspection readiness to ensure compliance with GxP and regulatory expectations. You will manage quality metrics and collaborate with cross-functional teams to drive continuous improvement and support the manufacturing of cell therapy products.

Responsibilities

• Plan, schedule and execute internal audits across all sites and functions in accordance with the internal audit program.
• 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 for global enterprise systems ensuring alignment with regulatory and internal requirements.

Required skills

• Quality Assurance
• Quality Systems
• GxP
• Internal Auditing
• Supplier Management
• Inspection Readiness
• KPIs
• Validation Oversight

Nice to have

• Multi-site quality management
• Global quality organization experience

Qualifications

• Bachelor's degree in a scientific or engineering discipline
• Advanced degree

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• PTO
• 401(k) plan
• Life insurance
• Accidental death and disability coverage
• Parental leave

About the Company

Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies. We are driven by a passion for science and compassion for patients, maintaining a start-up culture of camaraderie and leadership by example.