Quality Assurance Director, Life Sciences

3 weeks ago

Fargo, North Dakota, United States Danaher Corporation Full time
Quality Assurance Director, Life Sciences

At Danaher Corporation, we are committed to advancing science in meaningful ways. Our team of dedicated professionals shares this goal by combining best-in-class products and services with the ideal operating environment to lay the groundwork for vital new discoveries worldwide.

We believe people are our most valuable asset. As a Quality Assurance Director, you will be part of the Quality department located in Fargo, ND and will be On-site. Your role will be to create and execute on the Quality Assurance Strategy, ensuring the company is operating in accordance with applicable regulations, standards, and guidance related to clinical and commercial activities.

Key Responsibilities:

  • Develop and enhance phase-appropriate QMS programs that comply with industry standards for development through commercialization GMPs.
  • Establish and implement metrics for monitoring system effectiveness to enable sound quality decisions and to improve quality.
  • Provide leadership and management to direct reports, including day-to-day supervision, performance management, training, and planning.
  • Oversee and manage all aspects of quality functions for quality systems, product complaints, product quality review, lot disposition, and inspection and release of incoming raw materials.

Requirements:

  • 10+ years of relevant experience in a quality position, required with a minimum of 3 years in a managerial position.
  • Experience with final drug product manufacturing with incoming Quality Management Systems, Quality Assurance, and regulatory audits required.
  • Bachelor of Science required; life science-related field, preferred.
  • Knowledge and expertise in principles and current Good Manufacturing Practices (GMPs) in a development through commercial application, required.

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. Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value 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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