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Abstract

It is time for Quality leaders to not only fulfill the traditional role of ensuring cGMP compliance within the company but also take the Quality profession to the level of business leadership like Deming did in Japan after World War II. FDA has recently stated that they have low confidence in quality management maturity of the pharmaceutical industry.

For quality leaders to also become good business leaders we must educate them in ways that are different from what we currently do. The education should be in the 6 areas

  • Visibly Demonstrating Responsibility of Quality
  • Risk-Informed Decision Making and Communication
  • Engaging Employees to Continually Improve
  • Integrating Quality into the Company Strategy
  • Making Quality Operations a Financial Value
  • External Global Quality Leadership.

The benefit of this for companies will be that quality becomes a financial competitive advantage with more predictable performance, cost reductions over time, and employees that are engaged and focused on both patients and continual improvement opportunities.

DOI

https://doi.org/10.21427/pk1z-dv90

Creative Commons License

Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License
This work is licensed under a Creative Commons Attribution-NonCommercial-Share Alike 4.0 International License.

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