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Quality Advisor, Cell and Gene Therapy- Operations- Gaithersburg, MD

Местоположение Гейтерсберг, Мэриленд, США Идентификатор вакансии R-102415 Дата публикации 03/11/2021

Quality Advisor, Cell and Gene Therapy- Operations- Gaithersburg, MD

Would you like to apply your expertise to impact the Quality Operations in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

At AstraZeneca we are guided in our work by a strong set of values, and we’re resetting expectations of what a bio-pharmaceutical company can be. Be proud to play a critical role as the eyes and ears of our patients. Unafraid of the responsibility, we monitor and sign off each batch as if the medicine were for our own family. All our contributions add up to improving the quality of patients’ healthcare and ultimate their quality of life.

Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world.  This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most cutting-edge technology and lab spaces, all designed to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration.

The Gaithersburg site offers a variety of amenities to help boost productivity and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center. This is where you’ll find newly-designed, activity-based work spaces to suit a variety of working styles while increasing collaboration between teams.  Come and thrive in our vibrant, energizing, connected and encouraging culture and make a difference to patients. Hear from our Senior Leaders about why they know AstraZeneca is a great place to work. https://lnkd.in/g8APibK

As Quality Advisor you will join our growing Development Quality, Biologics division and report directly to the Director of Quality Assurance.  This position will play a pivotal role in managing the development, implementation and sustainment of the Quality Processes and Systems relating to Cell and Gene Therapy (C>) products.

What you’ll do

  • Effectively collaborate as part of a multidisciplinary team to develop novel cell therapies to treat diseases with C>.
  • Provide support to Quality Department projects such as in the Commissioning and Qualification activities for the new cGMP facility builds.
  • Implement and monitor the routine systems, procedures, and records to support cGMP manufacturing, testing and release of G> products.
  • Contributes towards the development of the Quality System infrastructure for C>.
  • Perform records review in a cGMP manufacturing environment with a focus on novel challenges of C>, as needed.
  • Support review of documents such as batch records, methods and validation protocols/reports.
  • Participate in quality investigations, assessments, and evaluations of quality records such as deviations, CAPAs, and change controls.
  • Provide hands-on QA support and oversight to internal staff to ensure compliance to SOPs and relevant Good Regulated Practice (GxP) requirements.
  • Provide guidance, interpretation, support, training, and input on the interpretation and implementation of regulations, guidelines, company procedures, and policies.

Essential for the role

  • Bachelors of Science degree, preferably in a Science related field.   
  • Minimum of 3 years’ experience in a cGMP role supporting Cell Therapy Products. 
  • Production knowledge of biotech products for clinical use in humans is required. 
  • Direct experience with quality investigations, assessments, reviews and/or evaluations of quality events such as CAPA’s, deviations, change control, etc. 
  • Excellent communication and interpersonal skills with the ability to influence to positive resolutions.
  • Strong decision making and problem solving abilities with the ability to identify creative solutions. 
  • Working knowledge of LEAN concepts is desirable.

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial -finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, groundbreaking cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.

So, what’s next!

Are you ready to bring new insights and fresh thinking to the table? Wonderful! We have one seat available and we hope it’s yours.

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a phenomenal fit, please share this posting with them.



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 authorisation and employment eligibility verification requirements.

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