On Monday (September 9th) I start as Head of Digital Quality at Brammer Bio, a division of Thermo Fisher Scientific. The symbolism of starting a new job in the fall in the United States, stands out to me.

I’ve been asked “Just what is digital quality?” To which the easy answer was, “What I do, but in the title.” It is important to expand on that definition here, because this is core to the concept of Quality 4.0.

On one level, adding the word digital in front of anything is kind of a buzz term. It is sort of the ‘i’ of decades past. Yep, head of iQuality, that means pretty much nothing.

There has been a ton written about just what digital is, and I am firmly rooted in the idea that digital should be seen less as a thing and more a way of doing things. Being digital requires being open to reexamining the entire way of doing quality, and that is exciting.

It is also not csv. Computer system verification/validation is a tool, but not an ends in itself. While I will always have one foot firmly in this skillset, I consider myself more a customer and an advocate here. Same goes for IT. IT provides services I make sue of. I’m a major stakeholder to IT, and hopefully an influencer, but I don’t do IT –fellow traveller, most definitely.

Nor is it data integrity, which is an objective or requirement to be met.

Being digital means being closely attuned to how quality, and the use of quality processes and tools, is evolving in the broadest sense. That means understanding how behaviors and expectations are developing inside the organization. It means being saavy to regulator and other stakeholder expectations as well as trends outside the pharmaceutical industry.

Yes it is about bringing in new tools. It is also recogning that the pharmaceutical industry has spent the last few decades building IT capability (ERPs and PAT and QMS and so much more) so a big part of the mission is rethinking how to use these and develop new capabilities to design and deliver the best possible quality experience, across all parts of the business. It is about implementing a cyclical dynamic where processes and capabilities are constantly evolving based on inputs from users and stakeholders, fostering ongoing use.

There is an interconnected set of three core capabilities that I think is crucial to this type of role:

Proactive decision making. Relevance is the currency of the digital age. This requires making decisions, based on intelligence, that deliver content and experiences that are personalized and relevant.

Contextual interactivity. Analyzing what is going on, and will go on, and bringing the right tools and decision-making to the job.

Journey-focused innovation. Quality should give permission and encourage the organization to innovate, expanding uses and deepening capabilities.

Being digital is about using data to make better and faster decisions, devolving decision making to smaller teams, and developing much more iterative and rapid ways of doing things. Thinking in this way shouldn’t be limited to just a handful of functions. It should incorporate a broad swath of how companies operate, including creatively partnering with external companies to extend necessary capabilities. A digital mind-set institutionalizes cross-functional collaboration, flattens hierarchies, and builds environments to encourage the generation of new ideas. Incentives and metrics are developed to support such decision-making agility.

So there’s my mini-manifesto of the journey I’m looking to continue on Monday, at Brammer.

Together with my ongoing activities in the Team and Workplace Excellence Forum of the ASQ, this job is really about what is most important to me: bringing great tools to the right teams to make the right decisions to ensure patient quality.