January 2023

· 6 min read

White Paper: How to Create More Expert Quality Leaders

NSF experts look at the four traits that define truly exceptional pharmaceutical quality leaders.
Speaker leading group discussion 53962423

We work closely with leadership at every level, especially with quality directors. One of the most popular questions that we get asked by C-suite executives when they are recruiting for senior-level quality roles is, “What’s the difference between leaders who excel and those who just get by?” NSF’s team of experts discussed this issue at a recent company event and arrived at four characteristics that make successful quality leaders stand out. Companies seeking quality excellence might look for candidates with these traits or work to instill them in their existing quality departments.

1. A Good Understanding of the Business (Not Just Quality and Compliance) and How Successful Leaders Think

Expert quality leaders have a strong sense of “why” that goes beyond their job description and inspires them and others. This starts with communicating that why to everyone and not just responding with “because GMP compliance says so.”

The best QA leaders have usually experienced life outside QA, giving them a broad understanding of the business, its challenges, its pain points and the power of collaboration. They understand the full product lifecycle from R&D to manufacturing, operations, logistics and supply chain. Their business knowledge allows them to think strategically, not just tactically.

They focus on future challenges, like “What impact will regulation X have?”, “How will I manage a 30% reduction in my budget over the next three years?”, “What impact will technology Y have in three years?” and “What are my group’s succession plans for the next three to five years?” They are prevention focused and consider crisis management and firefighting to be a sign of poor leadership and lack of strategic thinking.

How They Act

The most successful quality leaders we have met over our many years as a global pharmaceutical training and consultancy organization create rich networks inside and outside their business, and they are driven by the desire to help others. They speak the language of business, not just compliance; in other words, they are business and financially literate.

2. Jack of All Trades, Master of None

How Successful Leaders Think

Successful leaders don’t expect to know the answer to every question or to solve every problem. If they thought they could, they know they would be deluding themselves.

Rather, they have a broad understanding of the business that allows them to see patterns before problems occur. They are comfortable with uncertainty. As one great leader said, “Not knowing everything is okay. It’s the ability to ask the right question to the right person in the right way that matters — then to pause, genuinely listen, and question again and again.”

How They Act

Successful leaders have five to six accurate and reliable key performance indicators (and surveillance systems) to allow assessment of controls — all leading, not lagging, indicators. They do less and then obsess, and they practice the 80-20 principle, focusing 80% of their time on the 20% that matters — prevention, growth and improvement in things like:

  • People development
  • Simplification
  • Building and maintaining networks

The people who genuinely stand out are the ones who care for the development of their team. Much has been written about fortitude and grit in recent years by authors such as Bruce Daisley and Angela Duckworth. However, resilience is vital to withstand ongoing pressures and the demands of a senior quality role.

During our discussion about this topic at our offices in the UK, one of our consultants suggested that truly great leaders thrive on failure (FAIL = first attempt at learning). The ability to overcome adversity is a trait that many people lack, and the willingness to battle through adverse events and overcome them separates the great quality leaders from the rest. Other aspects we discussed include:

  • Viewing complacency as the biggest threat to their company’s future
  • Never taking criticism personally
  • Considering organizational agility to be more important than productivity
  • An obsession with simplification and the KISS (keep it simple, stupid) principle (After all, agility and simplification go hand in hand. You can’t have one without the other.)

To that end, the best people in our sector ensure that their deviation and CAPA, change control, and audit and self-inspection systems focus on removing complexity, not adding it.

3. Excellent Risk-Based Decision-Making and Being Comfortable in the Gray Zone

Successful leaders recognize that there are no such things as 100% compliance or zero risk. The ability to act decisively and to get the “big calls” right is vital. World-class quality leaders share many traits, including:

  • Avoiding paralysis by analysis (overthinking)
  • Acknowledging that risk aversion creates more risk by adding complexity and diluting accountability
  • Taking the 80-20 approach to avoid decision-making fatigue
  • Making decisions and placing logic (data) before emotion or gut feeling (which is wrong 80% of the time)
  • Considering collaboration and consultation before deciding (Quality leaders know that more minds can generate better decisions and more accurate risk assessments. They rarely decide in isolation.)
  • Being comfortable with constructive disagreements to challenge their understanding (They openly explore areas of disagreement to find the third way, rather than defend their position.)
  • Focusing on understanding before deciding (They know that decisions, well researched and understood, are easy.)

How They Act

We have observed that the most effective quality practitioners are the ones who make calm, methodical, data-driven and consistent decisions, typically following the same process or decision-making rules with clear “redlines” that are never compromised. These include:

  • I will never compromise patient safety.
  • I will never decide with a high level of uncertainty.
  • I will never decide purely on gut feeling.
  • I will never succumb to groupthink.

Perspective is important, and successful leaders always put some space and time between the event and the decision. We have found that the more important the decision, the bigger the space needs to be. They never make rash decisions, and they consult widely before making important ones (80% listening, 20% questioning).

The ability to make decisions is critical. However, the ability to look back at decisions and to question if the right one was made, and where lessons can be learned, is equally important. The self-help and motivational shelves in bookstores are filled with examples of sports figures and businesspeople who analyze performances and then implement changes to improve their next performance. These activities are not the sole preserve of that group. Quality leaders can and must assess what they have done and seek to consistently improve.

4. Successful Leaders Are Coaches, Mentors, Lifelong Learners and Delegators

We believe that leaders must create new leaders. To do that, there must be an environment of constant improvement of people. True quality leaders imbue a sense of purpose, responsibility and capability in their people. This enables team members to do their best work and carry it out with a sense of psychological safety. In doing so, they increase the chances that decisions are made in the best interest of the site.

NSF Can Help

Our team of ex-regulators and industry experts work with some of the world’s most acclaimed companies, and they interact daily with leading professionals in the quality, compliance and regulatory sectors. They can help you and your team with training, mentoring and consultancy support.

Additional Resources for Quality Leaders

Additional Resources on NSF’s Website

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