Service Quality Assurance Director, Life Sciences

2 days ago


Fargo, North Dakota, United States Danaher Corporation Full time
Job Summary

As the Director of Service Quality Assurance in our Life Sciences department, you will play a crucial role in shaping the future of medicine by advancing science in meaningful ways.

Main Responsibilities
  • Develop and implement quality assurance strategies to ensure compliance with regulatory requirements and industry standards.
  • Lead the creation, implementation, and maintenance of all quality and release processes to guarantee efficacy and safety.
  • Support the company in ensuring that it operates in accordance with applicable regulations, standards, and guidance related to clinical and commercial activities.
  • Collaborate with regulatory agencies and customers on quality and compliance issues, negotiating quality agreements as needed.
  • Oversee and manage all aspects of quality functions for quality systems, product complaints, product quality review, and lot disposition.
  • Establish and implement metrics for monitoring system effectiveness to enable sound quality decisions and improvements.
Requirements
  • 10+ years of relevant experience in a quality position, with a minimum of 3 years in a managerial role.
  • Experience with final drug product manufacturing, quality management systems, quality assurance, and regulatory audits.
  • Bachelor of Science required, life science-related field preferred.
  • Strong knowledge foundation of FDA and EU regulations regarding the manufacture of biologics, including regulatory inspection or support experience.
About Danaher

We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our company values diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace, and throughout the markets we serve.



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