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

AstraZeneca•Gaithersburg, MD

About The Position

At AstraZeneca Cell Therapy, the Senior Specialist, Cell Therapy Vein-to-Vein Process Excellence & Quality Operations supports the implementation, standardization, and continuous improvement of scalable Vein-to-Vein processes across the patient and product journey. The role translates approved operating models and process standards into practical workflows, controlled documentation, performance measures, and improvement initiatives that enable consistent, compliant, and inspection-ready execution. The position works across Vein-to-Vein Operations, Quality, Manufacturing, Clinical Operations, Digital, Trade Compliance, treatment sites, and external logistics partners to identify process gaps, strengthen operational controls, and support clinical-to-commercial growth. It promotes a patient-centered quality culture in which risks and potential issues are identified, escalated, and addressed proactively.

Requirements

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.

Nice To Haves

Experience in cell therapy, autologous supply chain, personalized medicine, or another patient-specific operating model.
Knowledge of patient and order orchestration, cold-chain logistics, and COI/COC traceability.
Experience supporting commercial launch readiness, clinical-to-commercial transition, or global network expansion.
Lean or Six Sigma training or certification.
Experience with FMEA, process governance, SOP/WI frameworks, digital capability deployment, and process-controlled change.
Experience with Excel, Power BI, Visio, Smartsheet, or similar process and analytics tools.

Responsibilities

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 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 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 protecting Chain of Identity and Chain of Custody, including 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.