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 companys 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 $100880.80 - $151321.20. Our positions offer eligibility for various incentivesan 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.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and 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.