Senior Cell Therapy V2V Process Excellence & Quality Ops

AstraZeneca plc; Gaithersburg (MD); On-site; USD 89,000 - 134,000; Full time

Benefits offered by this job

Long-term incentives

Retirement plan

Job summary

AstraZeneca Cell Therapy in Gaithersburg seeks a Senior Specialist, Cell Therapy V2V Process Excellence & Quality Operations to drive end-to-end Vein-to-Vein processes across patient and product journeys, translating operating models into workflows, documentation, and measurable improvements.

You will partner with Quality, Manufacturing, Clinical Operations, Digital, and external partners to map processes, embed GxP requirements, lead CAPA analyses, manage deviations, and support

Qualifications

• 5+ years of experience in biopharma, cell therapy, pharma supply chain, quality operations, process excellence, or another regulated environment.
• Experience mapping processes, optimizing processes, root-cause analysis, deviation and CAPA support, risk assessments, or continuous improvement.
• Working knowledge of GMP, GDP, GxP, controlled documentation, and inspection-readiness requirements.

Responsibilities

• Implement and continuously improve end-to-end Vein-to-Vein processes across the patient and product journey in line with process standards.
• Develop and maintain process maps, business rules, SOPs, and work instructions.
• Embed GxP, GDP, quality-by-design, and inspection-readiness into V2V processes and documentation.
• Partner with Quality and operations on deviation investigations, root-cause analysis, CAPA development and implementation, change controls, risk assessments, and effectiveness checks.
• Analyze deviations, exceptions, handoff failures, and trends; identify systemic gaps and propose improvements.
• Maintain and improve controls for Chain of Identity and Chain of Custody, with defined handoffs and escalation paths.
• Conduct readiness and gap assessments for new products, sites, countries, lanes, and service models; track actions to closure.
• Support clinical-to-commercial transition and launch readiness with established processes, documentation, training, and escalation mechanisms.
• Collaborate with Digital to translate process needs into requirements and support testing, deployment and adoption of V2V capabilities.
• Promote a patient-centered quality culture with proactive risk identification and escalation.

Skills

Analytical skills

Problem solving

Communication

Stakeholder management

Independent work

Education

Bachelor's degree in supply chain or related field

Tools

Excel

Power BI

Visio

Smartsheet

Job description

AstraZeneca Cell Therapy in Gaithersburg seeks a Senior Specialist, Cell Therapy V2V Process Excellence & Quality Operations to drive end-to-end Vein-to-Vein processes across patient and product journeys, translating operating models into workflows, documentation, and measurable improvements.

You will partner with Quality, Manufacturing, Clinical Operations, Digital, and external partners to map processes, embed GxP requirements, lead CAPA analyses, manage deviations, and support