Six Traits of Great Quality Business Leaders

Make Quality a Core Business Competency

In an increasingly complex world, successful quality leaders must go beyond their legally defined cGMP compliance role to demonstrate effective business leadership.

Illustration of quality business leaders

Forward-thinking quality leaders expand quality’s role to create a competitive advantage for their company. Specifically, great quality business leaders exhibit six key traits:

6 traits of of quality leaders shown in a circle

To master these traits, quality leaders must learn new ways of practicing quality. The new ways should be proactive; go beyond compliance; and focus on the company, patients, and employees.

Visibly demonstrate responsibility for Quality
1
Great quality business leaders assume responsibility for all aspects of quality and go beyond company-wide compliance with cGMP standards. Quality business leaders prevent issues, raise the quality bar, and demonstrate that non-compliance is unacceptable.
- Ensure all employees are well-trained in matters of quality.
- Act promptly in response to non-compliance.
Advocate that quality is owned by all through developing senior management partnerships
2
As business partners, quality leaders engage other functions within the company, particularly Manufacturing and the C-suite, to take collaborative ownership of quality.
- Ensure senior manufacturing and executive leaders communicate and demonstrate the importance of quality to all.
Engage employees to continuously improve quality
3
Quality business leaders create a psychologically safe environment where employees are encouraged to engage in and lead quality improvements.
- Provide ample opportunities for employees to volunteer in improvement projects.
Make risk-informed decisions that benefit patients
4
The decisions we make in the pharmaceutical industry aren’t always clear-cut. Our choices shouldn’t be based on compliance alone but should always be justified based on data, science, compliance, and a documented risk vs. benefit analysis that keeps patients in mind.
- Make evidence-based decisions for patients and the company, balancing benefits and risks.
Promote quality as a value-driven financial advantage
5
An effective quality business leader demonstrates quality as a business value in words, actions, and results. Quality business leaders should translate quality and compliance activities into financial terms.
- Use the quality system as an engine for quality and financial improvements.
- Speak both in cGMP and $GMP terminology.
Lead the path to one global quality regulatory framework
6
Diseases are global, and so are the drug products we produce. As quality leaders, we experience the challenge of diverse national regulatory agency expectations, which lead to unnecessary complexity in the supply chain.
- Allocate time for thought leadership to drive the regulatory framework toward one global standard based on science and data.