Associate Director Quality Control

10000929 - Assoc Director Study Management
Rockville, MD Full Time
POSTED ON 3/15/2024 CLOSED ON 3/29/2024

Job Posting for Associate Director Quality Control at 10000929 - Assoc Director Study Management

Are you ready to take the lead in ensuring the hard work from the rest of the business is realized, as we reliably get every medicine out to patients without challenge? We are looking for an Associate Director of Quality Control to support and manage Site Quality Control Operations at Cell Therapy 9950 MCD. This role involves managing quality control activities or site quality projects that support strategic and operational plans ensuring successful delivery of cell therapies to patients.  

What you will do:

As an Associate Director Quality Control, you will ensure that day-to-day QC laboratory operations are run efficiently. This includes resource planning, shift structure design, and organizational assignments. You will lead and develop people focusing on planning, communication, leadership, teamwork, problem-solving, performance management, and talent development. You will also ensure that operations are compliant with the cGMP standards established by AstraZeneca and relevant regulatory agencies.  

Minimum Qualifications:

  • B.S. degree in Science, Engineering, Pharmacy, or related technical field with a minimum of 5 years of applicable experience

  • Minimum of 3 years applicable with M.S. degree in Science, Engineering, Pharmacy, or related technical field 

  • Minimum 2 years of management experience 

  • Minimum 2 years of Cell Therapy/Biologics Quality Assurance experience including clinical lot release. 

  • Prior experience in Good Manufacturing Practice / Good Laboratory Practice and compliance management environment 

  • Experience of working cross-functionally across the supply chain with groups such as regulatory, Global Compliance Management Group, manufacturing, supply and capability, account management etc. 

  • Demonstrated ability to make decisions under pressure that balance patient safety, compliance, and supply.   

  • Excellent interpersonal skills in a cross-functional environment.   Excellent verbal and written communication skillsAbility to interact with all levels of management including senior management.

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.  

 

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

 

Why AstraZeneca? 

In Quality, our work is important and valued. An unrivalled forward-looking mindset, there's no better place to work at the forefront and learn how to add real value to a business throughout the lifecycle of our products. discovery, development, and commercialization. As the voice of the patient, every batch we certify is a personal stamp of approval. Not something we take lightly, we are always innovating, trailing the latest models and technologies to improve reliability and excellence in our processes. 

 

Are you ready to take on this exciting role? Apply now and join us in our mission to deliver life-changing medicines! 

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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Salary.com Estimation for Associate Director Quality Control in Rockville, MD
$228,755 to $311,602
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