Global Senior Cell Therapy QA Auditor

AstraZeneca; Gaithersburg (MD); On-site; USD 128,000 - 192,000; Full time

Benefits offered by this job

401(k) plan

Health benefits

Paid vacation

Job summary

The Senior QA Auditor position at AstraZeneca will be based in Gaithersburg, MD, Santa Monica, CA or The Netherlands. You will conduct independent audits across cell therapy manufacturing sites, suppliers, and services to ensure CGMP compliance, risk-based quality assurance, and regulatory readiness.

You bring 10+ years in QA auditing, strong knowledge of cell therapy, and excellent cross-cultural communication.

Qualifications

• 10 years experience in a QA environment with increasingly responsible job requirements including audit experience.
• Extensive knowledge of Cell Therapy Products and Cell Therapy Specific Regulations.
• AZ business language in English.

Responsibilities

• Conduct independent appraisals of quality and compliance systems within technically advanced manufacturing settings.
• Performs complex and demanding domestic and international audits of suppliers and contracted services.
• Plans, coordinates and conducts scheduled or unscheduled cGMP audits of internal AstraZeneca departments.
• Provide clear and scientifically/technically justified interpretations and support for audit findings and CAPAs.
• Liaise with local/global senior management to ensure issues are understood and actions are acceptable.
• Interpret and apply cGMP regulations and expectations.
• Demonstrate strong written and oral skills in cross-cultural settings.
• Initiate and maintain contacts with regulatory agencies and industry groups to stay updated.
• Develop and interpret audit findings to communicate trends and provide recommendations.
• Work with QA colleagues to ensure consistent interpretations of cGMP.
• Complete training on AZ Code of Ethics and Supporting Policies on time; report non-compliance.

Skills

Audit experience

Cell Therapy knowledge

Cross-cultural communication

Education

Bachelor's degree in a scientific discipline

Job description

The Senior QA Auditor position at AstraZeneca will be based in Gaithersburg, MD, Santa Monica, CA or The Netherlands. You will conduct independent audits across cell therapy manufacturing sites, suppliers, and services to ensure CGMP compliance, risk-based quality assurance, and regulatory readiness.

You bring 10+ years in QA auditing, strong knowledge of cell therapy, and excellent cross-cultural communication.