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Lieu: Frederick, Maryland, États-Unis
ID de l'offre 13158223
Date de publication: 08/30/2019

AtAstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.

As the Director – Quality Control you will be responsible for all aspects of QC at the Frederick Manufacturing Center, including the testing of raw materials, in-process, drug substance, drug product, stability and microbiology samples in support of late stage clinical and commercial programs. In this role you will be leading and developing a large QC team in a lean environment.

Responsibilities may also include oversight of some or all aspects of the late stage clinical or commercial drug product stability program, QC Analytical, QC Technical Services, QC Information Systems, QC Compliance Management, QC Planning, Environmental Monitoring or QC Sample Management.

Main Responsibilities:

  • You will play a key role defining the values, culture, and goals for the site.
  • Provide leadership, direction, and mentoring to ensure that the QC organization is successful in meeting the quality and manufacturing objectives in support of corporate goals.
  • Manage all aspects of analytical related activities during tech transfer and product commercialization.
  • Plan, design, and execute multiple simultaneous projects that are complex and technically demanding through significant interactions with internal staff and external experts.
  • Initiate, implement, plan, direct, and execute multiple simultaneous investigations to resolve deviations, understand trends, improve method and process performance.
  • Responsible for balancing day-to-day technical support and longer term projects, investigations, and project team responsibilities.
  • Responsible for maintaining technical expertise in analytical field and working knowledge of manufacturing processes.
  • Effectively present results at internal meetings and external scientific meetings.
  • Utilize forward-looking perspective to contribute to “go/no go” decisions.
  • Responsible for meeting project goals within time and budget constraints.
  • May make recommendations on outside technologies for company to pursue.
  • Generally indirectly or directly supervise lower-level scientists and associates.
  • Facilitate the growth and development of QC staff.
  • Demonstrate excellent communication skills through internal and external channels.

Minimum Requirements:

  • BS degree and 15+ years of relevant work experience
  • MS or PhD preferred
  • 10+ years of experience in commercializing and supporting commercial bio-therapeutics preferred
  • 10+ year of supervisory experience preferred

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.

Director Quality Control - Operations
Qualité

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