In a highly regulated industry like the pharmaceutical sector, there are strict rules and work routines in place to support and simplify daily tasks, but these rules and routines can also hinder and intimidate. Helena Fröstadius, educator and quality consultant, and Ellinor Crafoord, CEO and senior recruitment consultant, highlight the issue and want more people to discuss the phenomenon.

We have a strong drive to contribute to the development of the individual and, in turn, the development of the industry. Recently, we have also reflected on the fact that we consistently encounter people working within the quality function who are driven by the fear of making mistakes.

That in itself is not really surprising. There is every reason for QA employees in the pharmaceutical industry to be cautious, but when fear turns into paralysis or an unwillingness to make decisions, then we have a problem – one where a risk-based approach and creative thinking can be hindered.

In the pharmaceutical industry, we have established SOPs and procedures to guarantee high-quality, patient-safe products. Following the SOPs is a given, but just like life, pharmaceutical manufacturing is not black and white. There are gray areas, when something unexpected happens and what occurs is NOT described in regulations or SOPs. In those moments, courage is required to act and make decisions. A decision that, in hindsight, can be seen as 'right or wrong.'

There is not ONE solution, but we need to reflect on how we create a work environment that counters a vicious cycle of self-doubt and rewards creativity and courage. We want to highlight three areas that we believe are crucial:

1. The right person in the right role. Ensure that you recruit the right type of personality for the QA role. Regulations can be learned, but one's fundamental personality is harder to change. The QA role may not be suitable for someone who is anxiety-driven or an extreme 'people-pleaser.'

2. Organizational conditions. Policeman, naysayer, roadblock, stickler... The QA role has many nicknames, and they are not always positive. The perception of the QA function will determine its ability to thrive and perform its job.

3. Leadership – Leadership is crucial for creating a high level of psychological safety. We need leaders who shape QA employees to trust their judgment and dare to be creative within the established frameworks. We stick our necks out and claim that expertise is secondary to leadership ability.

/ Ellinor Crafoord, CEO at SallyQ & Helena Fröstadius, Utbildningsledare and Coach at Prudensa Consulting

Debattartikel publicerad i Life Science Sweden, augusti 2024.