Senior Specialist, Cell Therapy Vein-to-Vein Process Excellence & Quality Operations

Accountabilities

• Implement and continuously improve assigned end-to-end Vein-to-Vein processes across the patient and product journey, in alignment with approved process standards and governance.

• Develop and maintain clear, controlled process maps, business rules, playbooks, templates, decision trees, RACIs, SOPs, and work instructions.

• Embed GxP, GDP, quality-by-design, and inspection-readiness expectations into V2V operational processes and documentation.

• Partner with Quality and operational stakeholders on deviation investigations, root-cause analysis, CAPA development and implementation, change controls, risk assessments, and effectiveness checks, within assigned responsibilities.

• Analyze recurring deviations, exceptions, handoff failures, and operational trends; distinguish isolated execution issues from systemic process gaps; and recommend sustainable improvements.

• Maintain and improve operational controls that protect Chain of Identity and Chain of Custody, including defined handoffs, verification points, escalation pathways, and exception-management requirements.

• Conduct documented process-readiness and gap assessments for new products, treatment sites, countries, logistics lanes, and service models, and track identified actions to closure.

• Support clinical-to-commercial transition and launch readiness by ensuring processes, documentation, training, quality controls, and escalation mechanisms are established and operationally executable.

• Partner with Digital and business stakeholders to translate process needs into business requirements and support testing, deployment, and adoption of V2V capabilities.

• Promote a patient-centered quality culture in which risks and potential issues are identified, escalated, and addressed proactively.