Senior Quality Systems & Compliance Lead

AstraZeneca; Rockville (MD); On-site; USD 120,000 - 160,000; Full time

Job summary

AstraZeneca is seeking a Senior Quality Compliance professional to guide and improve site quality systems for autologous cell therapy manufacturing, covering deviations, CAPA, change control governance, and inspection readiness. The role involves cross-functional coordination and regulatory guidance across global standards.

The position requires strong cGMP knowledge, audit experience, and data-driven quality leadership to ensure regulatory compliance and patient safety across clinical and

Qualifications

• 7+ years quality experience with a science/engineering degree.
• Experience writing and investigating quality records.
• Proven ability to work in a fast-paced, cross-functional environment.
• Strong knowledge of cGMPs and ability to interpret regulatory requirements.
• Experience leading or supporting GxP audits or self-inspections, and supporting/hosting health authority inspections.
• Ability to analyze quality data, identify trends and risks, and prepare clear reports.

Responsibilities

• Support the effective execution and improvement of site quality systems.
• Prepare for, facilitate, and communicate outcomes of routine site Quality System governance meetings.
• Assist in Quality Management Review preparation with metrics and slides; track actions.
• Lead site self-inspections as a lead auditor and document findings; track corrective actions.
• Coordinate cross-functional inputs for Annual Product Quality Reviews.
• Support site inspection readiness initiatives and audit responses.
• Provide guidance on site compliance with global regulations and industry best practices.
• Develop dashboards and insights on quality metrics and trends.

Skills

Quality management

cGMPs knowledge

Audits & self-inspections

Data analysis & reporting

Stakeholder management

Facilitation

Cross-functional collaboration

Microsoft Office

Lead auditor training

Education

Bachelor's degree in science or engineering

Tools

Microsoft Office

Job description

AstraZeneca is seeking a Senior Quality Compliance professional to guide and improve site quality systems for autologous cell therapy manufacturing, covering deviations, CAPA, change control governance, and inspection readiness. The role involves cross-functional coordination and regulatory guidance across global standards.

The position requires strong cGMP knowledge, audit experience, and data-driven quality leadership to ensure regulatory compliance and patient safety across clinical and