Senior Cell Therapy V2V Process Excellence & Quality

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

Job summary

AstraZeneca Cell Therapy is expanding its Vein-to-Vein Operations and seeking a Senior Specialist to lead process excellence and quality across the patient and product journey. You will translate operating models into practical workflows, controls, and documentation to enable compliant, inspection-ready execution.

Collaborating with Quality, Manufacturing, Clinical Operations, Digital, and external partners, you will identify gaps, drive CAPA, risk assessment, and continuous improvement to

Qualifications

• Bachelor's degree in supply chain or a related field.
• 5+ years in biopharma, cell therapy, or regulated operations.
• Experience mapping processes and CAPA.
• Knowledge of GMP, GDP, and inspection-readiness.

Responsibilities

• Implement and improve Vein-to-Vein processes across the patient and product journey.
• Develop and maintain process maps, rules, SOPs, and playbooks.
• Embed quality and inspection-readiness into operational processes.
• Lead deviation investigations, CAPA, and risk assessments.
• Support clinical-to-commercial transition and launch readiness.

Skills

End-to-end Process Excellence

Quality Operations

GxP knowledge

Process mapping

Stakeholder management

Analytical thinking

Independent work

Education

Bachelor's degree in supply chain or related field

Tools

Excel

Power BI

Visio

Smartsheet

Job description

AstraZeneca Cell Therapy is expanding its Vein-to-Vein Operations and seeking a Senior Specialist to lead process excellence and quality across the patient and product journey. You will translate operating models into practical workflows, controls, and documentation to enable compliant, inspection-ready execution.

Collaborating with Quality, Manufacturing, Clinical Operations, Digital, and external partners, you will identify gaps, drive CAPA, risk assessment, and continuous improvement to