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

AstraZeneca is hiring a Senior Specialist, Cell Therapy Vein-to-Vein Process Excellence & Quality Operations. It pays $89k-$134k a year and Level rates it Little AI ●○○○; you can [apply on AstraZeneca](https://jobsbylevel.com/go/3bcea1e3-6978-4a92-899f-a553cd750439?utm_medium=ai-agent).

AI Level 1, AI centrality 38 out of 100. US - Gaithersburg - MD.

## Details

- Company: [AstraZeneca](https://jobsbylevel.com/companies/astrazeneca)
- AI level: AI Level 1 (score 38 out of 100)
- Location: US - Gaithersburg - MD
- Salary: $89k-$134k
- Posted: November 3, 2026
- Apply: https://jobsbylevel.com/go/3bcea1e3-6978-4a92-899f-a553cd750439?utm_medium=ai-agent
- Free CV review for this job: https://jobsbylevel.com/cv-review?job=senior-specialist-cell-therapy-vein-to-vein-process-excellence-quality-operations-at-astrazeneca-bdb19a

## Description

At AstraZeneca Cell Therapy, we are building the capabilities required to deliver complex, personalized therapies through a highly coordinated, patient-centered operating model. As we strengthen our Vein-to-Vein Operations, we are increasing our focus on standardized execution, patient and product traceability, proactive exception management, operational performance, and quality. The Senior Specialist, Cell Therapy V2V Process Excellence & Quality Operations will support the implementation, standardization, and continuous improvement of scalable Vein-to-Vein processes across the patient and product journey. The role will translate approved operating models and process standards into practical workflows, controlled documentation, performance measures, and improvement initiatives that enable consistent, compliant, and inspection-ready execution. Working across Vein-to-Vein Operations, Quality, Manufacturing, Clinical Operations, Digital, Trade Compliance, treatment sites, and external logistics partners, you will identify process gaps, strengthen operational controls, and support clinical-to-commercial growth. 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. Essential Skills/Experience Bachelor's degree in supply chain or a related field. At least 5 years of relevant experience in biopharma, cell therapy, pharmaceutical supply chain, quality operations, process excellence, or another regulated operational environment. Demonstrated experience in process mapping, process optimization, structured root-cause analysis, deviation and CAPA support, risk assessment, or continuous improvement. Working knowledge of GMP, GDP, GxP, controlled documentation, and inspection-readiness requirements. Experience translating complex operational requirements into clear processes, standards, procedures, and business requirements. Strong analytical, problem-solving, facilitation, communication, and stakeholder-management skills. Ability to work independently, manage multiple priorities, and influence Operations, Quality, Digital, Manufacturing, Clinical, and external partners in a matrix environment. Desirable Skills/Experience Experience in cell therapy, autologous supply chain, personalized medicine, or another patient-specific operating model. Knowledge of

The description is cut here. Read the full offer: https://jobsbylevel.com/jobs/senior-specialist-cell-therapy-vein-to-vein-process-excellence-quality-operations-at-astrazeneca-bdb19a

Source: https://jobsbylevel.com/jobs/senior-specialist-cell-therapy-vein-to-vein-process-excellence-quality-operations-at-astrazeneca-bdb19a

## Cite this page

Level. https://jobsbylevel.com/jobs/senior-specialist-cell-therapy-vein-to-vein-process-excellence-quality-operations-at-astrazeneca-bdb19a.

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