Director, Cell Therapy Quality Assurance

AstraZeneca; Rockville (MD); On-site; USD 175,000 - 262,000; Full time

Job summary

AstraZeneca in Rockville, MD is seeking a Director of Quality Assurance to lead the Site Quality Assurance Operations at the Cell Therapy facility. You will shape strategic and operational plans, drive high-level projects, and define innovative solutions across complex quality domains to enable safe, compliant manufacturing.

You will manage a cross-functional team, partner with senior leaders, oversee investigations, CAPAs, deviations, and change controls, and ensure readiness for health

Qualifications

• Minimum BS in Science, Engineering, Pharmacy, or related technical field with at least 8 years of relevant experience.
• MS in Science, Engineering, Pharmacy, or related field with at least 5 years of relevant experience.
• Minimum 5 years of management experience.
• At least 2 years in Cell Therapy/Biologics QA including clinical lot release.
• Experience with product launches, health authority inspections, and global distribution requirements.
• Ability to make decisions under pressure balancing patient safety, compliance, and supply.
• Ability to influence senior stakeholders internally and externally.

Responsibilities

• Lead the new Quality Assurance team at the Cell Therapy facility, supporting start-up and routine production.
• Partner with senior AstraZeneca leaders to deliver an integrated Cell Therapy QA approach.
• Participate in investigations, assessments, and evaluations of quality records (deviations, CAPAs, change controls).
• Manage, develop, and lead a team of QA professionals.

Skills

People management

Regulatory affairs

Quality system oversight

Process improvements

Stakeholder influence

Leadership

Education

B.S. degree in Science, Engineering, Pharmacy, or related technical field

M.S. degree in Science, Engineering, Pharmacy, or related technical field

Job description

AstraZeneca in Rockville, MD is seeking a Director of Quality Assurance to lead the Site Quality Assurance Operations at the Cell Therapy facility. You will shape strategic and operational plans, drive high-level projects, and define innovative solutions across complex quality domains to enable safe, compliant manufacturing.

You will manage a cross-functional team, partner with senior leaders, oversee investigations, CAPAs, deviations, and change controls, and ensure readiness for health