Senior Specialist Quality Engineer

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. Responsibilities You will 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 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 years of Cell Therapy/Biologics Quality Control experience Minimum of 1 years 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 - $151,321.20. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans. Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form. #J-18808-Ljbffr AstraZeneca GmbH