AstraZeneca
Quality Systems and Compliance Lead
US - Rockville - MD · Senior
Sponsorship not specifiedDetected 2 days ago
Data AnalysisAuditingFDA RegulatoryCommunicationGxP
Stay score
odds of building a lasting career here
42Risky
Cap-exempt (no lottery)0
Sponsors this role100
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
Thin sponsorship signal and lottery-bound. A low-probability bet with your clock running. Prioritize cap-exempt roles and proven entry-level sponsors first.
Lottery odds assume a STEM candidate.
Personalize to your clock →Community outcomes
No reports yet — be the first to help the next applicant.
About the role
- If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
Skills
- 7+ years applicable quality experience with bachelor's degree in science, engineering, or related technical field.
- Experience writing and investigating quality records.
- Proven track record to work in a fast-paced environment across multiple technical functions
- Experience leading or supporting GxP audits or self-inspections, as well as supporting/hosting health authority inspections.
- Strong facilitation, written communication, and stakeholder-management skills.
- Proficiency with electronic quality systems, reporting tools, and standard Microsoft applications.
- Demonstrated ability to make decisions that balance patient safety, compliance and supply.
- Master's degree in science, engineering or related technical field.
- Autologous cell therapy manufacturing or quality experience.
- Experience preparing or coordinating Annual Product Quality Reviews.
- Working knowledge of international Cell Therapy GxP regulatory frameworks, regulations and guidance.
Compensation
- The individual will serve as a key point of contact for deviation and CAPA management, change control governance, Quality Management Review preparation, and Annual Product Quality Reviews for an autologous cell therapy manufacturing site wi
Apply directly at AstraZeneca →Create a free account for alerts like thisView AstraZeneca immigration profile
This listing is sourced directly from AstraZeneca's careers page and normalized into a canonical job model.