Director Quality Assurance

About the role

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 work on diversified tasks with a global team, gaining exposure to new ways of thinking and contributing to collective and individual growth.

Responsibilities

• 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.

Requirements

• 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.

Pay

The annual base salary for this position ranges from $174,856 to $262,285 USD. Base pay offered may vary depending on market location, job-related knowledge, skills, and experience. The position also offers a short-term incentive bonus opportunity and eligibility to participate in our equity-based long-term incentive program.

Benefits

• Qualified retirement program (401(k) plan).
• Paid vacation and holidays.
• Paid leaves.
• Health benefits including medical, prescription drug, dental, and vision coverage.

Schedule

In-person working with an expectation of a minimum of three days per week from the office. The company balances this expectation with respect for individual flexibility.