Director 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

Join us as a Director Quality Assurance, where you will lead and direct the Site Quality Assurance Operations at our Cell Therapy 9950 MCD Rockville manufacturing site. This role offers an opportunity to develop strategic and operational plans, lead high-level projects, and define innovative solutions within complex areas of the business. You will be working on diversified tasks with a global team, providing you with exposure to new ways of thinking and helping us grow collectively and as individuals.

What You Will Do

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

Minimum Qualifications

• B.S. degree in Science, Engineering, Pharmacy, or related technical field with a minimum of 8 years of applicable experience
• M.S. degree in Science, Engineering, Pharmacy, or related technical field with a minimum of 5 years of applicable experience
• Minimum of 5 years of management experience
• Minimum of 2 years of Cell Therapy/Biologics Quality Assurance experience including clinical lot release
• Experience with product launches, health authority inspections, and global commercial product distribution requirements
• Proven ability to work in a fast-paced environment across multiple technical functions.
• Demonstrated ability to make decisions under pressure that balance patient safety, compliance, and supply.
• Ability to influence senior stakeholders, both internally and externally

Preferred Qualifications

• Advanced degree in Science, Engineering, Biochemistry, Pharmacy, or related technical field
• Minimum of 2 years of Cell Therapy Quality Assurance experience including clinical lot release
• Demonstrated track record in leadership of change management in a positive and non-disruptive manner to the company's values.
• Experience with Cell Therapy regulatory inspections
• Experience engaging with global regulatory bodies.
• Proven track record of attracting and developing talent.
• Extensive working knowledge of international Cell Therapy GxP regulatory frameworks, regulations, and guidance

The annual base salary for this position ranges from $174,856 - $262,285 USD. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program. Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility.

Join us in our unique and ambitious world.

At AstraZeneca, we take Quality seriously. Our work is important and valued. We are always innovating, and trialling the latest models and technologies to improve reliability and excellence in our processes. We are proactive, science-based, and solutions-oriented. It's our ambition to go far that keeps pushing us forward. But it's our pragmatic focus that keeps us delivering what will have the biggest impact on our patients. We are strong communicators and networkers. With constant exposure to different tasks, we're at our best when we're working together as a team.

Date Posted

06-Aug-2026

Closing Date

20-Aug-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.