Senior Quality Engineer, Cell Therapy Risk & Validation

AstraZeneca; California (MD); On-site; USD 100,881 - 151,321; Full time

Job summary

AstraZeneca in Tarzana, CA, is seeking a Sr. Specialist Quality Engineering to oversee Quality Risk Management, CQV, and CSV programs for the Cell Therapy operation. You will provide leadership and strategic direction to the QE organization, ensuring cGMP compliance and regulatory readiness.

You will mentor QE teams, collaborate across functions, and ensure Quality oversight of validation, data integrity, and transfer activities to support site goals and compliant manufacturing.

Qualifications

• 6+ years of applicable experience in quality/QA
• 1+ years Cell Therapy/Biologics Quality Control experience
• 1+ years of management/supervisory/project management experience preferred
• Experience with health authority inspections and global distribution requirements
• Ability to influence senior stakeholders

Responsibilities

• Provide leadership, direction and mentoring to ensure QE organization meets quality and manufacturing objectives
• Represent QE on site governance and teams, externally as needed
• Support Quality Site Lead, Compliance and Site Support for operational growth
• Own the Quality Risk Management program and Risk Registry
• Oversee CQV/Validation programs with strategic planning for validation teams
• Oversee CSV program with IT and validation teams
• Support Data Integrity compliance and cross-functional Tech Transfer/Change Controls/Deviations/CAPAs

Skills

Leadership

Project management

Influence stakeholders

Communication skills

Education

B.S. degree in Science/Engineering/Pharmacy

M.S. degree in Science/Engineering/Pharmacy

Job description

AstraZeneca in Tarzana, CA, is seeking a Sr. Specialist Quality Engineering to oversee Quality Risk Management, CQV, and CSV programs for the Cell Therapy operation. You will provide leadership and strategic direction to the QE organization, ensuring cGMP compliance and regulatory readiness.

You will mentor QE teams, collaborate across functions, and ensure Quality oversight of validation, data integrity, and transfer activities to support site goals and compliant manufacturing.