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Quality Supplier Manager - Pharmaceutical Operations- Gaithersburg, MD

Lieu Gaithersburg, Maryland, États-Unis Job ID R-094666 Date de publication 12/07/2020

Quality Supplier Manager- Pharmaceuticals 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? 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.  

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.

The Quality Supplier Manager will perform supplier qualification and monitoring and associated activities (risk assessments, investigations, complaint handling, etc.) to maintain license to operate.  This person will be responsible for monitoring the availability of suppliers for products in their assigned clinical portfolio.

Main Responsibilities:

  • Operate as the AstraZeneca Quality point of contact for Contract Manufacturers (CMOs) and Contract Testing Labs (CTLs), providing on-site support/oversight as necessary.
  • Independently author and negotiate Quality-based agreements or sections of agreements for CMOs, Clinical trials or Inter-company/Partner relationships.
  • Maintain strong working knowledge of CFRs, EuDRA and associated guidance’s, regulations and annexes.
  • Provide review of master and executed batch records and support disposition of materials.
  • Lead and assess Supplier Initiated Changes.
  • Assist in Product Complaint and Non-Conformance investigations.
  • Effectively handle the enforcement of contractual obligations while maintaining strong supplier relationships. 
  • Maintain computerized documentation systems.
  • Participate in continuous improvement through the use of Lean tools and principles.

Minimum Requirements:

  • B.A. or B.S. in Biology, Biochemistry, Chemistry, Engineering or related fields and 7+ years of pharmaceutical industry experience.
  • M.S. in related field and 5+ years.
  • Minimum of three (3) years supplier management experience necessary.
  • Previous manufacturing experience desirable.
  • Previous large molecule / small molecule experience desirable. 
  • Strong relationship management skills with the ability to lead difficult conversations to positive resolution. 
  • Demonstrated experience in meeting contending deadlines. 

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.

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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