Senior Specialist, Cell Therapy Vein-to-Vein Operations

At Astra Zeneca , we are advancing an ambitious vision incell therapyto deliver transformative treatments through innovative science, operational excellence, and uncompromising quality. The
Senior Specialist, Cell Therapy Vein-to-Vein Operations
plays a key role in strengthening the quality backbone ofV2V Operations, supporting compliant, timely, and risk-based execution across a dynamic, patient-focused environment. This role helps protectCOI/COC integrityacross thevein-to-vein product journey, enabling reliable and compliant execution and strongdelivery performance. It is a high-impactsenior individual contributorposition for someone motivated by improving quality processes in practice, partnering with SMEs to solve problems, and translating quality data and documentation into meaningful action and continuous improvement.

You may be based in Tarzana, CA or Gaithersburg, MD and report to the Senior Director, Global Logistics.

• Lead and coordinate quality recordsforV2V Operations, includingchange controls, deviations, and CAPAs, from initiation through closure, ensuring timely progression, complete documentation, and alignment with internal quality expectations.

• Partner with SMEs and process ownersto develop robust and compliant record content, including problem statements, impact assessments, root cause analyses, corrective and preventive actions, implementation plans, and effectiveness considerations.

• Review and challenge documentation qualityto ensure records are clear, scientifically sound, appropriately justified, traceable, and consistent across related records and supporting documentation.

• Drive follow-up and maintain visibility of record status, action progress, aging, and closure timelines, escalating concerns where compliance, quality, or delivery is at risk.

• Facilitate and support quality risk assessmentsrelated toV2V activitiesandCOI/COC-related processes, ensuring risks, controls, residual risks, and mitigation plans are clearly documented and linked to appropriate actions.

• Maintain alignment between risk assessments, quality records, and procedural controlsso that risk-based decisions are consistently reflected across documentation and operational practice.

• Support the lifecycle management of quality procedures, includingSOPs, work instructions, templates, and other controlled documents, through drafting, revision, review coordination, implementation support, and periodic maintenance.

• Help ensure procedures remain current and effective, aligned with operational practice, quality requirements, lessons learned, and outcomes from deviations, CAPAs, audits, inspections, and trend reviews.

• Compile, analyze, and communicate quality metrics and trendsfor theV2V Operation steam, including measures such as record volume, aging, overdue actions, closure timeliness, recurrence, CAPA implementation, and procedural compliance indicators.

• Translate quality data into actionable insights by identifying recurring themes, emerging risks, and improvement opportunities, and by supporting governance discussions and management review.

• Support continuous improvement by using learnings from quality records, metrics, audits, inspections, and stakeholder feedback to strengthen processes, documentation quality, and preventive controls.

• Escalate significant quality, compliance, timing, or resource risksthrough the appropriate management and Quality channels, applying sound judgment on matters requiring higher-level attention.

• Support inspection and audit readinessthrough accurate documentation, effective tracking, organized record management, and readiness of quality system evidence relevant toV2V Operations.

• Collaborate effectively across functionswithV2V Operations SMEs,Quality Assurance, technical teams, and other stakeholders to ensure timely and compliant execution of quality system activities.

• Bachelor’s degreein ascientific, technical, engineering, quality, or related discipline, or equivalent relevant experience.

• 5+ years' experience in aGxP-regulated environment with solid knowledge ofquality system sand documentation requirements.

• Demonstrated experience…