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Device Quality Manager- Global Operations US/UK

Location Gaithersburg, Maryland, United States Coppell, Texas, United States Newark, Delaware, United States Wilmington, Delaware, United States Mount Vernon, Indiana, United States Macclesfield, England, United Kingdom Job ID R-157340 Date posted 29/01/2023

Device Quality Manager- Operations

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? AstraZeneca is a science-driven biopharmaceutical company with a pipeline of exciting new medicines with an array of modalities. We are dedicated to discovering, developing, and delivering innovative, meaningful medicines and healthcare solutions that enrich the lives of patients. 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.

The Device Quality Manager will be responsible for leading quality planning and improvement activities, partnering with sites and global functions and influencing at multiple levels of the organization in order to ensure our device products remain in compliance with the applicable regulations.  They will provide specialist quality leadership and support for commercialized Combination Products and Medical Devices. This role will work with internal and external partners to provide portfolio-level device quality support. 

Main Responsibilities:

  • Provide Device Quality support to Device Technical Leads of above-site / multi-site Combination Products and Medical Devices in support of device compliance maintenance activities (e.g Design History File, Device Master Records etc.).
  • Provide Device Quality support for above-site / multi-site change assessments for Combination Products and Medical Devices, defining quality strategies, priorities and plans as required for evaluation activities.
  • Provide Device Quality expertise in support of Site Device Quality SMEs.
  • Support Supplier Quality Managers by providing Device Quality expertise to address risk management, change control, quality or auditing activities.
  • Lead or support above-site / multi-product responses to Device-related issues to ensure a coordinated and consistent approach.
  • Provide above-site / multi-site Device Quality support for the handling and trending of device related complaint records.
  • Provide Device related Quality support during the transfer of both new projects and established products to internal and external manufacturing sites.
  • Support actions required as a result of updates or new standards or requirements.
  • Identify and deliver improvement opportunities related to the Combination Product and Medical Device Quality Management System, ensuring compliance to all applicable regulations.

Minimum Requirements:

  • BS and/or MS in engineering or equivalent technical discipline
  • Seasoned experience working with Combination Products and/or Medical Devices, ideally in a Post-Production (Operations) setting.
  • Extensive knowledge of both US and International device requirements (specifically 21 CFR Part 4, Part 820, ISO 13485, ISO 14971, Medical Device Directive 93/42/EEC).
  • Understanding of the overall drug and device development and commercialization process from development, launch and through life cycle management.
  • A good technical knowledge of one of the key portfolio technology areas (parenteral, inhalation, software).
  • Evidence of excellent communication skills and building excellent relationships with internal and external customers.
  • Project management skills with a track record of successful delivery within a matrix organization.
  • Ability to develop solutions to a diverse range of problems using structured problem-solving tools and sound analytical and conceptual thinking

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 great fit, please share this posting with them.

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About Operations

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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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.