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Associate Director Quality - Operations

Plats Gaithersburg, Maryland, USA Jobb-id R-065994 Datum inlagd 11/15/2019

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 Associate Director Quality, you will be responsible for the QA leadership of the External Suppliers of Drug Substance and Drug Product.  This represents global responsibilities and accountabilities for the compliance and Quality Assurance management of the suppliers manufacturing Biologic drug substance or drug product or OTLs performing critical testing for drug substance or drug product. 

Main Responsibilities:

  • Lead the QA Function that is responsible for:
  • Providing QA support to DS and DP teams responsible for delivering cost savings and value creation actions outlined in the category plan
  • Quality Assurance aspects of establishing new external suppliers of Drug Substance and Drug Product for AZ.
  • Ongoing management of supplier quality performance, product delivery, Regulatory compliance and continuous improvement for a portfolio of global external suppliers
  • QA relationships interface for all global external suppliers for these products
  • QA oversight of manufacturing and disposition of outsourced DS and DP inclusive of issue management
  • Significant input to the development of strategies and lead the implementation of these to improve the overall performance of the GSQ portfolio over time
  • Act as a representative of GSQ Suppliers on AZ projects
  • Host and interact with Regulatory Inspectors during inspections within AZ and at suppliers as per quality Agreements
  • Represent AZ at Quality and Business Review meetings as required
  • Represent AZ GSQ at professional organization meetings

Minimum Requirements:

  • Bachelors Degree in Chemistry, Life Sciences or Engineering required

Preferred:

  • Masters Degree in Quality Assurance/Regulatory Affairs or other advanced scientific field desired
  • Significant line management experience
  • Experience of working with global external suppliers desired
  • Business, financial and supply chain understanding/awareness
  • EH&S, GMP and regulatory management knowledge
  • Lean manufacturing principles, understanding, experience and practitioner

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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