Senior Specialist Quality Engineer

About the role

You will oversee the Quality Risk Management, Commissioning Qualification & Validation (CQV), and Computerized System Validation (CSV) programs for the Cell Therapy operation at the Tarzana facility. This includes Quality Review and Approval for Quality Risk Assessments, Technical Reports, Validation Planning, Change Controls, Validation Protocols, and Reports. You will lead the technical quality arm of the Quality department, ensuring compliance with cGMP standards established by AstraZeneca and relevant regulatory agencies.

Responsibilities

• Provide leadership, direction, and mentoring to ensure the QE organization meets quality and manufacturing objectives in support of site goals.
• Represent the QE department and/or the Quality Organization on assigned site governance and operational teams internally, and as an empowered functional representative externally to align deliverables with site business objectives.
• Support the Quality Site Lead, Compliance, and Site Support for operational and long-term growth, demonstrating excellent communication skills through internal and external channels.
• Own the site’s Quality Risk Management program, including generation and maintenance of the site’s Risk Registry.
• Provide quality oversight of the Commissioning, Qualification, and Validation Program through strategic planning, leadership, and guidance to validation teams.
• Provide quality oversight of the Computerized System Validation Program through strategic planning, leadership, and guidance to the CSV and IT teams.
• Provide quality oversight and support for the Data Integrity Compliance program.
• Offer technical quality support to cross-functional teams responsible for Tech Transfers, Change Controls, and Deviations-related CAPAs.

Requirements

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

Pay

The annual base pay for this position ranges from $100,880.80 to $151,321.20. Eligibility for various incentives includes short-term incentive bonuses, equity-based awards for salaried roles, and commissions for sales roles.

Benefits

• Qualified retirement programs.
• Paid time off (vacation, holiday, and leaves).
• Health, dental, and vision coverage in accordance with the terms of the applicable plans.