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Quality Assurance Manager, Biologics- Gaithersburg, MD

Plats Gaithersburg, Maryland, USA Jobb-id R-124315 Datum inlagd 11/23/2021

At AstraZeneca we turn ideas into life changing medicines and strive to continuously meet the unmet needs of patients worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

As the QM you will be responsible for product release and management of product Quality Complaints. The successful candidate will have experience in Mammalian Cell Culture Production to include monoclonal antibody production, Microbial Fermentation, Drug Product filling, and Label and Packaging.

You will be a member of the External Sourcing & Logistics Quality (ESLQ) Organization.  We have a dynamic team that supports all our synthetic and Bio products globally to help patients live better lives.   

Main Duties and Responsibilities

The incumbent is responsible for the Quality management of assigned Quality system and compliance activities for ESLQ supply chains and suppliers. They are responsible for all Quality activities that directly support execution of assigned Quality Management System elements. QMs will be assigned key areas of responsibility, but will be expected to learn other areas of the quality system to help support the rest of the team during times of peak workload or vacation coverage.

This includes, but is not limited to:

Product Release - Assigns Usage Decision for Drug Substance, Drug Product, Finished Pack

• Batch record reviews (including certificates of analysis/conformance, assessment of deviations as required) including working in relevant quality management systems (SAP, TrackWise, Veeva).

• Assign Usage Decision for batches affected by Critical deviations, assessed by Senior Quality Supplier Manager or Qualified Persons

Complaints Management - Coordinate complaints issued for ESLQ as a supplying site or coordinating site

• Product Quality Complaints

• Temperature Excursion

• Supply and Logistics (support when applicable)

• Product security

Additional Responsibilities may include:

• Deviation investigations, quality issue management and escalation

• Quality system element governance as either BPO or deputy BPO

• Change control

• SOP management

• Self-Inspection Auditing

This position requires strong cross-functional ways of working with non-Quality members across the Supply Chain.

Key Accountabilities

  • Batch review and disposition of biologics products manufactured at a Contract Manufacturer.
  • Generation/investigation/closure of reported product events
  • Maintains a high level of understanding of meaningful biologic production processes and quality systems.
  • Performs the Quality review and/or approval of the following cGMP documentation for Biologics suppliers: Change Controls, Quality Investigations (Deviations, Product Quality Complaints)
  • Quality issues escalation and resolution with our Suppliers, to ensure right product at the right time is delivered into the Product Supply Chain.
  • Supporting internal cost saving initiatives, value creation, performance standards, continuous improvements, and issue resolution
  • Collaborates in data analysis and report creation on quality metrics and key performance indicators

Essential Requirements

  • Bachelor degree in a science / technical field such as Pharmacy, Biology, Chemistry or Engineering.
  • 4+ years broad experience in either the pharmaceutical operations environment or pharmaceutical Quality Assurance role.  Strong proven knowledge of Biologic processes, cGMPs, Quality Systems and the pharmaceutical supply chain environment. Also, strong understanding of industry standards such as Pharmacopeia, ISO standards, etc.
  • Proven experience working cross- functionally
  • Ability to work independently under your own initiative

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.

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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AstraZeneca has taken critical steps to protecting colleagues, loved ones, and patients from COVID-19 and its variants.  COVID-19 vaccination is required for all US employees, and weekly PCR COVID-19 testing is required for those who are unvaccinated or have an approved accommodation.

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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