Join us at AstraZeneca as a Quality Assurance Associate Director, where you will be supporting and managing Site Quality Operations at Cell Therapy 9950 MCD. This role is pivotal in managing quality assurance activities and site quality projects that support strategic and operational plans, ensuring successful delivery of cell therapies to patients. You will be implementing innovative solutions within the most complex and ambiguous areas of the business, managing and providing direction for the quality on the floor organization through a comprehensive understanding of site and global issues.
What you will do:
Drive the delivery of day-to-day Quality Assurance activity within a specific site, ensuring adherence to plan and schedule while aligning with global operations as necessary.
Provide advice and knowledge in interpreting Good Manufacturing Practice guidelines and regulations.
Contribute/lead significant local/cross-functional or global projects/initiatives and influence decision-making within Quality Assurance and the line functions/skills groups, including senior management.
Have direct involvement in regulatory inspections and be responsible for drug substance/drug product supply management.
Through the use of Lean initiatives, you will drive out any non-value-adding activities and drive productivity improvements and overall equipment effectiveness.
Manage and coach multiple Quality professionals operating within the cell therapy manufacturing suite(s) and manage risk using evaluative judgment in complicated or novel situations.
Minimum Qualifications:
B.S. Degree or equivalent professional qualification in a science/technical field such as Pharmacy, Biology, Chemistry
Minimum of 5 years applicable experience (BS degree)
Minimum of 3 years applicable experience (M.S. degree in Science, Engineering, Pharmacy or related technical field)
Minimum of 2 years of management experience
Minimum of 2 years of Cell Therapy/Biologics Quality Assurance experience including clinical lot release.
Preferred Qualifications:
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
At AstraZeneca, our work in Quality 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 a team of ambitious people who want to go far. We are strong communicators and networkers, working together as a team to get our pipeline out to patients sustainably, reliably, and safely. We follow evidence to reach outcomes that benefit patients and AstraZeneca. Accompanied by our digital and Lean evolution in Operations, we have a sharp focus on patient-centricity, constantly asking what more we can do to deliver to patients safely.
Are you ready to make a difference? Join us now and accelerate our Lean journey! Take advantage of the huge opportunities to drive efficiencies in our processes and produce better-quality outputs. Now is the time to join and make a bigger impact, as we commit and accelerate our growth in Lean. Apply now!
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
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