By Jason Cachia
While I’m not a technical expert within Quality, I speak to executives every day who are. Common topics keep coming up in our discussions that I feel inclined to share and raise awareness of in hopes of bridging the gap between organisations. While this information is shared with me, organisations aren’t sharing it with each other, which is what prompted me to write this article.
If life science organisations want to discover and distribute life-saving drugs and treatments, then Quality is a strategic imperative.
Patient safety is the absolute goal for any life sciences organisation. Quality is a strategic imperative that’s embedded in the cultural fabric of an organisation. It makes sense then to think of Quality first, whose purpose it is to ensure that the high-quality standards and universal regulations are adhered to in order to save lives and ensure patient safety.
When pharmaceutical products are taken to market and Quality is prioritised, patient-centricity is ensured, and every dose is consistent and of high-Quality standards. With rigorous standards, regulations and Quality processes in place, life science organisations can protect their reputations before the product is even commercialised.
But is Quality being prioritised already? When modern Quality thinking is applied, what are the best-in-class practices organisations have adopted?
Based on my discussions, high performing Quality organisations adopt the following approaches:
1) Senior leaders embrace quality and drive this from the top-down
2) A trusting, transparent and cross-collaborative culture is a must
3) The use of technology to make data-driven decisions
The best in class organisations use Quality to their advantage to embrace flexibility and agility, create a nimble organisation, and adjust to regulatory and industry demands. So, how do these organisations drive Quality up the agenda?
Driving Quality up the agenda
Previously, Quality was seen as a policing type role, instead of a partnership. Rather than discussing how Quality could be implemented to achieve business goals, it was often just thought of as outdated policies and procedures that slowed productivity and momentum down.
The whole purpose of Quality is to ensure that products are safe, compliant, and effective. It’s clear that for Quality to be successful, it must be driven from the top down. This means there must be buy-in from the senior leadership team across the entire organisation and not just the Quality leader.
Kelly Thomas, Vice President Americas Quality Operations stated:
“Driving Quality up the agenda is not a one-man project. It’s for the entire organisation to get involved in so everyone must know the roadmap and the benefits of prioritising Quality as a company, individual and unit. Pushing Quality is all about communication and gaining buy-in so that not only do you as a Quality leader have more support, but everyone in the organisation feels part of what you’re trying to achieve”.
Savvy Quality leaders understand how to impart the importance of Quality at all levels of an organisation. At the executive level, Quality is ensuring every patient experience is met with the highest standards. This mindset allows executives to remain flexible and entrepreneurial as regulations and industry needs shift. With Quality filtering down from the C-suite, the broader organisation can embed Quality related initiatives in each department’s goals.
Having the right Quality procedures in place will help to keep the standard of Quality high across each function in a life sciences organisation.
It’s important to create an environment which enables cross-collaboration to thrive. Teams must be able to speak the language of other functions and work towards one common goal without compromising the Quality of the product. If there is no culture change, then none of this is possible.
From my conversation with Katie Terry, VP of Quality, she said:
“Establishing cross-collaborative relationships is important to build that feeling of trust that makes people feel comfortable coming to you with questions and concerns”.
Transparency and the sense of speaking freely promotes healthy debates illuminating risks and challenges. This type of culture also ensures all teams are working towards a singular goal.
An effective way to build cross-collaborative relationships is to digitise some processes and procedures. It’s well known in the life sciences that a lot of relevant information is buried deep in paper records. As such, the information and data that teams need to do their jobs is not easily accessible to them all. When new technologies are utilised to digitise information, it streamlines operations and improves partnerships with Quality.
With digitisation, cross-collaborative partnerships thrive as each department would have access to data in real-time, without the complication or inconvenience of paperwork.
Blake Jensen, VP, Quality and Compliance stated that:
“Quality needs to share the information with everyone. Being digital helps make data available and means everyone can work together more effectively. While Quality can analyse the data, it’s operations that act upon it and make strategic changes.”
It should be noted that digitisation is no small feat, and the digitisation process can take some time since changes may require new validation from regulatory authorities. It can be expensive but identifying key areas that can have an immediate impact on streamlining cross-collaboration and organisational growth should be prioritised. When the necessary steps are implemented successfully, it has the potential for an even higher standard of Quality.
What I’m seeing from a market point of view are several Quality individuals that possess cross-collaboration and digital process implementation experience in driving Quality up the agenda.
I recently asked my network what they think the main reason is for Quality being low on the agenda and 51% of respondents voted for outdated views on Quality. Even though some organisations have modern approaches to Quality and view it as a strategic imperative, there is still work to be done.
My advice to Quality leaders would be if you don’t have experience in doing at least one of these strategies, start thinking about it now. Not only can it help your organisation’s performance, but it also enables you to truly excel in your career – something that I know everyone is motivated by.
For more information…
- Read our blog: Are Local CDMOs Going To Save Pharma?
- Read our blog: Is It Time To Bring Drug Manufacturing Back To The US?
- View our talent solutions to see how we can help you gain a competitive edge through talent.
* Fraser Dove International is a talent consultancy operating exclusively across the life sciences industry. While our roots lie in executive search, we provide more than the traditional recruitment services. Uniquely placed within the market, we have been providing cutting-edge talent solutions and insight to organisations at all stages of their journey – from start-up to established leaders – since 2013.