Senior Specialist Quality Engineer

AstraZeneca • Los Angeles, CA

1d

About The Position

As the Sr. Specialist Quality Engineering (QE) you will be responsible for the oversight of 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. You will ensure that operations are compliant with the cGMP standards established by AstraZeneca and relevant regulatory agencies.

Requirements

• 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 years of Cell Therapy/Biologics Quality Control experience
• Minimum of 1 years of management/supervisory/project management experience 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

Nice To Haves

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

Responsibilities

• Provide leadership, direction and mentoring to ensure that the QE organization is successful in meeting the 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 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 Computerized 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

Benefits

• qualified retirement programs
• paid time off (i.e., vacation, holiday, and leaves)
• health, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Senior