It's Time for Quality Leadership in the Pharmaceutical Industry

In the course of our work on organization transformation and leadership at Kotter International, we challenge and explore how individual leaders (and leadership teams) - can have an impact in accelerating their business results.

The influence of the quality function within organizations has been growing significantly in recent years, and our work alongside leaders, engineers, and technicians in quality functions in various industries has reinforced the role that individuals in the quality function can - and should - have if they are looking to lead change. In a world that needs more than ever to be able to respond rapidly to emerging threats (Zika Virus), leadership within pharma quality is essential. The upside is that this new leadership makes business sense too: in a recent interview with Johnson & Johnson Chairman and CEO Alex Gorsky on CNBC, the impact of the transformation in the quality function across many operating facilities was highlighted as one of the main attributes that has fueled the significant performance turn around for J&J.

One of the pioneers of the new Quality function who we have worked with is Anders Vinther, Chief Quality Officer at Sanofi Pasteur. Anders' opinions on leadership within quality are bold and provocative for a function that has traditionally been viewed as an "enforcer of rules" rather than as an "innovator."

Here, Anders shares his thoughts on what the future of the Quality function should be.

How is the Quality Organization seen in your company?

For many years, I think we - in quality functions in the pharmaceutical Industry - have mostly been seen as the 'police and enforcement,' and it is time to change this if we are to achieve our true objective: engaged employees and a sustainable supply of quality medicines.

Quality should be leading and innovating - and not merely enforcing.


It has been almost 40 years (1978) since the GMPs (good manufacturing practices) were fully introduced into our pharmaceutical industry as our 'traffic code' -- setting clear expectations on what needs to be documented and how we must produce medicines. The GMPs were introduced for good reasons: to ensure drug products are safe, efficacious and meet predetermined quality standards -- because there were examples of this not being the case. The exact same standards have now applied for all these years but think about how the world has changed from 1978 to now in so many ways and in so many areas. In 1978, the people producing medicines were the silent generation; since then we've had the baby boomers, generation X, Y and soon it will be generation Z that will produce the medicines of the world. Each generation has its own preferred way of working, but are we -- in the quality organization and are health authorities trying to hang on to the "old way" of doing things? Are we seen as custodians of history and the enforcing police officers of GMP compliance? Are we clinging on to old ways of working through traditional procedures and controls? I fear we are.

Delivering a Predictable Outcome

Generally, our quality systems and procedures are designed to meet the GMP requirements, to be prescriptive, and to be predictive. And we need them to be because we all want medicines to be the same quality -- batch after batch after batch.

However, the way that we have set about delivering this quality has led to an environment where improvements to processes and systems are typically gradual and linear -- focusing on reducing waste and variability. Our ability to learn and adapt fast is seriously hampered by this approach. We focus on training people in reading and understanding standard operating procedures (SOPs, 'user manuals' or 'recipes' for operations), and when our employees make mistakes we often re-train them and add more details into these SOPs. We also focus on what to do and how things must be done and much less so on the why, which would put things in perspective in the broader context. We aren't delivering innovations in quality the way we should -- and could be. While there is any number of reasons for this, I suspect that primarily we have been focusing on describing our operations in the greatest detail to reduce variability in our operations and even amongst our employees. We have not paid enough attention to leveraging the differences we have as human beings -- and how we when building on our differences can create much better solutions to our daily work and objectives. Additionally, as a broad workforce, we differ from generation to generation in how we prefer to perform our work. Our systems have not fully embraced new technologies as these have evolved over time. The way that we approached quality in the past is not the way that we should be approaching quality today.

In the old paradigm companies often, through the decisions that they make and the actions that they take, demonstrate that they view quality as a cost rather than a value-adding function for the business. Doing the right investments upfront in prevention and anticipating risks often fail to happen and instead we spend much more time and money after the risk happened writing investigation reports and fixing issues.

A New Era for Quality

It is time for quality to be leaders in the pharmaceutical industry, to reverse the trend of drug shortages and inadequate innovation, and to stop antiquated and 'mono-channel' ways of working. It is time for quality to be a movement for change, to be seen as a business partners at the 'C-suite' level, to speak the language of the business, and to lead in new and adaptive ways of working at all levels taking into active use new technologies and spanning generation gaps when it comes to preferred way of working. It is time to broaden our approach, not keeping it narrow.
The key focus areas for us should include identity, information, and relationships:

  • Identity linking the role of the individual to the role we have as an industry to improve public health (with the specificities of your particular company). We want to move from 'have to' to 'want to', from being told to do your daily work routines, to have our employee volunteer to improving how we work in a 'co-creating' fashion. And we want to speak with and involve our employees in every ways that works for them, also when it comes to creating SOPs and improving SOPs, etc.
  • Information and knowledge sharing through social media tools and informal settings, adopting new technologies in operations, simplify our systems to be much more effective, and through adult learning methods, rather than training by slide decks or lengthy procedures; yes, it is possible to "fix" a quality issue through a mindset shift rather than through another page in an SOP.
  • Relationship building at all levels and across the entire company - not managed through the traditional hierarchy, silos, and manager self-importance. Analogous to the campaign in many cities that encourages citizens "if you see something, say something", the quality function should be leading the change to create an environment where if employees see something, they can call it out, identify the remediation action needed, and be encouraged for improving the overall system. A healthy pharma industry needs a living quality ecosystem - not a top-down, rule-heavy, enforcement based culture.
It's time for Quality Leadership.
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