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Location:
Coppell, Texas, United States
Job reference: R-045454
Posted date: Feb. 22, 2019
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At AstraZeneca, we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We're focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life.

As a Senior Manager Quality Control at our growing manufacturing facility in the Dallas Fort Worth, Texas area, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives.  The manufacturing facility in Coppell, Texas produces the drug substance Lokelma, approved to treat hyperkalemia and is the global supply site for this novel product.

You will provide expert technical and analytical leadership, advice and direction to the Quality Control function including instrumentation and methodology troubleshooting, non-routine analysis, and the evaluation and exploitation of new technology.  You should be qualified to graduate level or equivalent in a scientific discipline, with extensive experience working in a Good Manufacturing Practice laboratory environment.  The incumbent will have strong knowledge and understanding of analytical chemistry and laboratory instrumentation, as well as Good Manufacturing Practice/Good Laboratory Practice.  The role requires a comprehensive understanding of the Quality Control function and its role and importance to the wider business.

Additionally, you must be proficient in Lean and the application of Lean in the laboratory environment.  You will be responsible and accountable for the throughput in the QC laboratories to support business demands.

Main Responsibilities:

  • Deliver QC operational performance. Ensure QC capacity and capability is in place to meet demand.
  • Work as part of the Americas and Global QC network to standardize ways of working, share best practice and integrate into the AstraZeneca supply network, supporting the Lean Labs global initiative.
  • Provides analytical expert knowledge and support to the Quality Control Function for the most complex troubleshooting issues, novel situations and oversees the delivery of training and coaching.   Optimizes performance outcomes of direct reports and ensures individuals understand the contribution they make.
  • Oversees the analytical technology transfer of Quality Control methodology into and out of QC Operations
  • Leads and directs the introduction of new technology and systems into the Quality Control Function, oversees and manages initiatives to ensure that the Quality Control function remains contemporary and competitive
  • Follows AZ’s financial policies, manages people resources to policy requirements and delivers the QC budget.
  • Monitors and maintains compliance in accordance with cGMP, SHE, SOX and business procedures. Is accountable for ensuring compliance is understood and maintained across the QC labs.  Uses expert knowledge to support regulatory inspections where required
  • Accountable for the delivery of a Lean and Agile work culture in the lab environment emphasizing standard ways of working and continuous improvement.

Minimum Requirements:

  • Bachelor’s degree in a science or engineering curriculum.
  • 10 - 15 years of experience as a Quality professional in the pharmaceutical manufacturing industry (finished drug product or Active Pharmaceutical Ingredients / complex chemical processing of excipients), with a minimum five to seven years in managerial / leadership positions.
  • Demonstrated Lean experience and understanding.
  • Advanced knowledge of cGMP requirements, quality systems, applicable to the QC Operations
  • Demonstrated management skills; ability to influence and engage direct and indirect reports and peers.
  • Strong written, oral, interpersonal, and presentation skills and the ability to effectively interface with all levels of management and staff.
  • Must be willing to address emergent factory quality and compliance issues by being available via telephone during off hours.

Preferred:

  • Graduate degree in engineering, science, or business is desirable.
  • Application of Lean ways of working in the QC environment.

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 is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law

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Senior Manager Quality Control
QA

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