# Senior Specialist Quality Engineer

**Company**: Cell Therapy Operations Quality Engineering
**Location**: Tarzana, California, United States of America
**Work arrangement**: onsite
**Experience**: senior
**Job type**: full-time
**Salary**: The annual base pay for this position ranges from $100,880.80 to $151,321.20
**Category**: Engineering
**Industry**: Healthcare

**Apply**: https://astrazeneca.eightfold.ai/careers/job/563877690435240?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
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## Description

As a Senior Specialist Quality Engineer, you will be responsible for overseeing the Quality Risk Management, CQV, CSV programs for the Cell Therapy operation of the Tarzana facility. This includes Quality Review and Approval for including Quality Risk Assessments, Technical Reports, Validation Planning, Change Controls, Validation Protocols, Reports, as well as leading the technical quality arm of the Quality department.

Responsibilities:

- Provide leadership, direction and mentoring to ensure that the QE organisation is successful in meeting the quality and manufacturing objectives in support of site goals.

- Represent the QE department and/or the Quality Organisation on assigned site governance and operational teams internally, and as an empowered functional representative externally to ensure deliverables are aligned with site business objectives.

- Provide support to the Quality Site Lead, Compliance and Site Support, for operational and long-term growth, and demonstrate excellent communication skills through internal and external channels.

- Own the sites Quality Risk Management program, including generation and maintenance of the sites Risk Registry

- Quality oversight of the Commissioning, Qualification, and Validation Program by providing strategic planning, leadership and guidance to the validation teams as needed.

- Quality oversight of the Computerised System Validation Program by providing strategic planning, leadership and guidance to the CSV and IT teams as needed.

- Quality oversight and support of Data Integrity Compliance program.

- Technical Quality support to cross functional teams responsible for Tech Transfers, Change Controls, Deviations related CAPAs

Minimum Qualifications:

- B.S. degree in Science, Engineering, Pharmacy, or related technical field with a minimum of 6 years of applicable experience

- M.S. degree in Science, Engineering, Pharmacy, or related technical field with a minimum of 3 years of applicable experience

- Minimum of 1 year of Cell Therapy/Biologics Quality Control experience

- Minimum of 1 year of management/supervisory/project management experience preferred

- Experience with product launches, health authority inspections, and global commercial product distribution requirements preferred

- Proven ability to work in a fast-paced environment across multiple technical functions.

- Demonstrated ability to make decisions under pressure that balance patient safety, compliance, and supply.

- Ability to influence senior stakeholders, both internally and externally

Preferred Qualifications:

- Advanced degree in Science, Engineering, Biochemistry, Pharmacy or related technical field

- Demonstrated track record in leadership of change management in a positive and non-disruptive manner to the company's values.

- Experience with Cell Therapy regulatory inspections

- Experience engaging with global regulatory bodies.

- Proven track record of attracting and developing talent.

- Extensive working knowledge of international Cell Therapy GxP regulatory frameworks, regulations, and guidance

The annual base pay for this position ranges from $100,880.80 to $151,321.20.

## Skills

### Required
- Quality Risk Management
- CQV
- CSV
- Quality Review and Approval
- Quality Risk Assessments
- Technical Reports
- Validation Planning
- Change Controls
- Validation Protocols
- Reports
- Leadership
- Mentoring
- Communication
- Data Integrity Compliance
- Tech Transfers
- Deviations related CAPAs
- Product launches
- Health authority inspections
- Global commercial product distribution requirements

### Nice to have
- Advanced degree in Science, Engineering, Biochemistry, Pharmacy or related technical field
- Leadership of change management
- Cell Therapy regulatory inspections
- Engaging with global regulatory bodies
- Attracting and developing talent
- Extensive working knowledge of international Cell Therapy GxP regulatory frameworks, regulations, and guidance

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