Senior Specialist Quality Engineer
About this opportunity
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.
Date Posted
12-Aug-2026
Closing Date
30-Aug-2026 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.
Job details
How this role compares
Computed from every other active Quality role in our database, not just this employer's listings.
We currently track 136 comparable Senior Quality roles across 36 biopharma companies.
Salary context
34 of 136 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 136 comparable roles
+ 15 more countries
Seniority mix
136 of 136 peers have a known seniority level
Therapeutic area mix
0 of 136 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
No peers with a known therapeutic area yet.
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.