Quality Systems & Compliance Lead (Cell Therapy)

AstraZeneca plc; Rockville (MD); On-site; USD 101,000 - 151,000; Full time

Benefits offered by this job

Health benefits

Retirement plan

Paid time off

Health, dental, vision coverage

Job summary

AstraZeneca plc is seeking an experienced Quality Assurance professional to guide site Quality Systems and regulatory compliance for autologous cell therapy manufacturing. You will own deviation/CAPA management, change control governance, and quality review preparations, coordinating with cross-functional teams across time zones to ensure GxP compliance.

The role requires 7+ years in quality, strong cGMP knowledge, and audit experience, with emphasis on data analytics, site inspections, and

Qualifications

• 7+ years quality experience with bachelor’s degree in science, engineering, or related technical field.
• Experience writing and investigating quality records.
• Proven ability to work in fast-paced cross-functional environments.
• Strong knowledge of cGMPs and regulatory interpretation.
• Experience leading or supporting GxP audits or self-inspections.
• Ability to analyze quality data, identify trends, and prepare reports.
• Strong facilitation, written communication, and stakeholder-management skills.

Responsibilities

• Guide execution and continuous improvement of site quality systems and compliance.
• Coordinate and lead site self-inspections and audit readiness activities.
• Support Quality Management Review and annual product quality reviews.
• Develop metrics, dashboards, and reports for quality data analysis.
• Coordinate deviations, CAPA, change controls, and related records.
• Liaise with global stakeholders across time zones for harmonized QA practices.

Skills

Quality systems knowledge

cGMP knowledge

Audit coordination

GxP audits/inspections

Data analysis

Regulatory interpretation

Stakeholder management

Written communication

Electronic quality systems

Microsoft Office

Education

Bachelor’s degree in science/engineering

Master’s degree (preferred)

Tools

Electronic QA systems

Microsoft Office

Job description

AstraZeneca plc is seeking an experienced Quality Assurance professional to guide site Quality Systems and regulatory compliance for autologous cell therapy manufacturing. You will own deviation/CAPA management, change control governance, and quality review preparations, coordinating with cross-functional teams across time zones to ensure GxP compliance.

The role requires 7+ years in quality, strong cGMP knowledge, and audit experience, with emphasis on data analytics, site inspections, and