Director Quality Assurance

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 companys 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 $174856 - $262285 base pay offered may vary depending on multiple individualized factors including market location job-related knowledge skills and addition our positions offer a short-term incentive bonus opportunity; eligibility toparticipatein 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 coveragein accordance withthe terms and conditions of the applicable 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 -person working gives us the platform we need to connect work atpaceand challenge we work on average a minimum of three days per week from the office. But thatdoesntmeanwerenot 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. Its our ambition to go far that keeps pushing us forward. But its 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 were at our best when were working together as a team.

Ready to make a difference Apply today!

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Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and 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.