Senior Specialist, Cell Therapy Vein-to-Vein Operations

AstraZeneca•Gaithersburg, MD

1d•Hybrid

About The Position

At AstraZeneca, we are advancing an ambitious vision in cell therapy to 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 of V2V Operations, supporting compliant, timely, and risk-based execution across a dynamic, patient-focused environment. This role helps protect COI/COC integrity across the vein-to-vein product journey, enabling reliable and compliant execution and strong delivery performance. It is a high-impact senior individual contributor position 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.

Requirements

Bachelor’s degree in a scientific, technical, engineering, quality, or related discipline, or equivalent relevant experience.
5+ years' experience in a GxP -regulated environment with solid knowledge of quality systems and documentation requirements.
Demonstrated experience with deviations, CAPAs, change controls, and controlled document management.
Experience supporting or facilitating quality risk assessments.
Experience drafting, reviewing, or maintaining SOPs or similar controlled procedures.
Experience compiling, reviewing, or interpreting quality metrics and trend data.
Strong written and verbal communication skills, with the ability to work effectively across technical and non-technical stakeholder groups.
Strong organizational skills and the ability to manage multiple priorities and deadlines with limited supervision.

Nice To Haves

Experience in cell therapy, supply chain, manufacturing
Familiarity with COI/COC-related processes and associated quality expectations.
Experience working in a cross-functional or matrixed environment.
Experience supporting audits, inspections, or internal quality reviews.
Working knowledge of root cause analysis tools, risk management methodologies, and continuous improvement practices.

Responsibilities

Lead and coordinate quality records for V2V Operations, including change controls, deviations, and CAPAs, from initiation through closure, ensuring timely progression, complete documentation, and alignment with internal quality expectations.
Partner with SMEs and process owners to 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 quality to 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 assessments related to V2V activities and COI/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 controls so that risk-based decisions are consistently reflected across documentation and operational practice.
Support the lifecycle management of quality procedures, including SOPs, 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 trends for the V2V Operations team, 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 risks through the appropriate management and Quality channels, applying sound judgment on matters requiring higher-level attention.
Support inspection and audit readiness through accurate documentation, effective tracking, organized record management, and readiness of quality system evidence relevant to V2V Operations.
Collaborate effectively across functions with V2V Operations SMEs, Quality Assurance, technical teams, and other stakeholders to ensure timely and compliant execution of quality system activities.