IT Quality Assurance Director is responsible for planning and directing the policies, programs, and initiatives used to monitor and measure the overall quality of IT services, systems, and software. Ensures that tracking systems capture useful operational metrics for use in reducing defects, improving service, and optimizing the implementation process. Being an IT Quality Assurance Director requires a bachelor's degree. Typically reports to a top management. The IT Quality Assurance Director manages a departmental sub-function within a broader departmental function. Creates functional strategies and specific objectives for the sub-function and develops budgets/policies/procedures to support the functional infrastructure. To be an IT Quality Assurance Director typically requires 5+ years of managerial experience. Deep knowledge of the managed sub-function and solid knowledge of the overall departmental function. (Copyright 2024 Salary.com)
Are you ready to lead and direct the Site Quality Control (QC) Operations at our Cell Therapy manufacturing facilities? We are looking for a dynamic leader who can develop strategic and operational plans to ensure the successful delivery of QC activities. The Director Quality Control role requires innovative thinking within complex and ambiguous areas of the business. You will be leading other managers and providing strategic direction for the QC organization through a comprehensive understanding of global issues.
What you will do:
Lead, create, and staff the new Quality Control organizational structure for the Commercial Cell Therapy Facility.
Partner with senior leaders across AstraZeneca to identify and remove blockers to ensure delivery of an integrated approach to Cell Therapy Quality across the business.
Oversight of all aspects of QC at the Cell Therapy Facility, potentially including testing of raw materials, in-process, viral vector, drug substance, drug product, stability, and microbiology samples in support of late-stage clinical and commercial programs.
Facilitate the growth and development of QC staff, demonstrate excellent communication skills through internal and external channels, support organizational objectives, and interpret company policies.
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 Control 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
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 trialing the latest models and technologies to improve reliability and excellence in our processes. We take Quality seriously and draw learnings from others to develop and understand what it takes to drive our modern mindset forward. Here you'll feel empowered to step up, and follow the science and evidence to make decisions that put patients first. We are a team of ambitious people who want to go far and we're all here to achieve. 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.
Are you ready to join a team where every voice is heard and matters? 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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