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Director of Quality Engineering

2 months ago

Gaithersburg, United States AstraZeneca Full time
Job Description

Intro to role

As the Director of Quality Engineering, you will provide leadership, direction and mentoring to ensure that the QE organization is successful in meeting the quality and manufacturing objectives in support of site goals. You will represent the QE department and/or the Quality Organization on assigned site governance and operational teams internally, and as an empowered functional representative externally to ensure results are aligned with site business objectives. You will facilitate the growth and development of QE staff, provide strategic support to the Quality Site Lead, Compliance and Site Support, for operational and long-term growth, and demonstrate excellent interpersonal skills through internal and external channels.

Essential Skills/Experience

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 Control experience including clinical lot release
• Experience with product launches, health authority inspections, and global commercial product distribution requirements
• Proven track record 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 partners, both internally and externally

Desireable Skills/Requirements

Advanced degree in Science, Engineering, Biochemistry, Pharmacy or related technical field
• 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

When we put unexpected teams in the same room, we fuel 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.


Date Posted

08-Jul-2024

Closing Date

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.