Embedding cultural change at pace in a complex GxP environment

To build early traction and energise teams, the transformation programme was delivered through a series of sprints. Each sprint tackled one pain point at a time and produced a tangible output, whether an end-to-end process framework or learning asset, that teams could use immediately. This created a predictable rhythm of engagement, co-creation, and visible progress. 

Each sprint was led by a sprint lead and supported by a core team, with participation rotating based on the topic. Wider SMEs were engaged as needed to test and validate solutions. This structure forced teams to think deliberately about scope, roles, and dependencies, while giving dedicated focus to a single pain point and solution. 

Over the course of the programme, more than 50 stakeholders from across Development, including Clinical Operations, Quality Assurance, Manufacturing, and Alliance Management, took part in ~20 sprints. By utilising this delivery approach teams were more engaged with the content and able to understand, absorb and align perspectives from a broad range of stakeholders and validate solutions created against their daily needs.   

All solutions were made available via a central digital hub for teams to access and provide feedback, allowing iterative improvements. By delivering tangible outputs at pace, the sprint model generated strengthened collaboration, and created the ownership needed to maintain momentum. 

Behaviours sit at the heart of any transformation. They determine how people work, make decisions, and interact every day. An organisation’s core values are generally a reflection of the behaviour expectations within teams. In GxP environments, compliant processes alone don’t create an inspection-ready organisation. What truly builds confidence and readiness are the consistent daily habits of individuals – how they document, hand off, collaborate, and problem-solve in real time.  

We define the behaviours driving transformation across three domains: 

Throughout the programme, teams deliberately identified and prioritised vital behaviours. After each sprint, a change impact assessment surfaced both the technical changes in process and the behaviours required to sustain it. For example, when Biomarker Leads identified the need for greater visibility and transparency from Lab Operations teams on resource availability and risks (communication, social).  

Across multiple sprints, three key behaviours were identified: communication, collaboration and leadership all within the 'Social' domain. These three were prioritised over personal or cognitive behaviours because inspection readiness depends less on individual capability and more on how teams interact, align, and take ownership under scrutiny. Communication, collaboration, and leadership directly influence cross-functional consistency, escalation, and decision-making in the areas where most compliance risks emerge.   

Delivering new processes and frameworks was only part of the transformation. The greater challenge was embedding change so that quality became the default mindset and way of working. Three elements proved critical: 

• Collaborative design from the bottom up gave sprint teams the ownership to shape solutions that were practical and adoption-ready 
• Visible leadership sponsorship from the top down provided credibility, alignment, and the space for teams to focus on transformation while sustaining delivery; 
• Habit Labs translated change into daily practice by focusing on behaviours as well as processes 

Habit Labs were designed to make change tangible by translating GxP processes and inspection requirements into the daily behaviours needed to execute them consistently. Drawing directly on pain points and areas of contention surfaced during sprints, each Habit Lab used real-world scenarios to simulate frictions teams faced, e.g. unclear hand-offs, decision bottlenecks, or cross-functional misalignment that could create compliance risk or slow progress.  

In facilitated sessions, teams role-played critical moments, challenged assumptions about accountability, and reflected on how individual choices, communication styles, and behaviours either enabled or obstructed progress. They worked through questions such as: How should this process be executed? Who is accountable at each step? Which behaviours should leaders and teams’ model to help ensure quality? These discussions exposed both positive and unhelpful behaviours, showing teams how their actions could either reduce or increase compliance risk. Each session concluded with teams identifying and committing to a set of small, repeatable habits they could apply immediately in their daily work. 

This behaviour-led approach helped bridge the gap between process design and lived practice. By grounding habits in actual challenges raised by teams, Habit Labs helped teams move beyond compliance to develop inspection-ready habits, strengthen cross-functional collaboration, and build a shared understanding of what “good” looks like in practice. 

A further layer of support came through the activation of a change champion network. Champions were nominated by leadership for their strong mindsets, subject matter expertise, and ability to influence within their functional teams. These individual set expectations locally, modelled desired behaviours, and provided a first line of support for questions and concerns. To equip them for this role, champions participated in targeted capability-building sessions covering practical skills in project management, communication, and change delivery. This created a confident, consistent voice for change across teams and helped sustain momentum well beyond the programme concluding. 

To maintain the health of all end-to-end processes, a strong governance structure is essential. In this programme, that accountability was anchored in the role of a Global Process Owner (GPO). In a GxP context, GPOs are essential: they provide end-to-end ownership of their process,  ensuring it is standardised, compliant, and inspection-ready. Just as importantly, effective GPOs translate strategic intent into operational practice, embed new ways of working into daily operations, and drive continuous improvement as regulations, technology, and business needs evolve. 

The GPO is accountable for owning end-to-end process KPIs, using data to continuously track process health, efficiency, and compliance. They review insights regularly, update processes based on evidence and feedback, and escalate when more substantial transformation programmes are required ensuring performance is not just monitored, but actively improved beyond the project end date.  

A GPO’s ability to embed and sustain change rests on several critical success factors: 

• Clear accountability: GPOs were explicitly empowered to own the outcomes of the end to end process, not just oversee documentation 
• The right profile: Individuals were selected for their deep domain expertise, ability to think systemically, and skill in aligning stakeholders across functions 
• Balance of compliance and adaptability: GPOs safeguarded inspection readiness while enabling processes to flex with new tools and shifting requirements 
• Continuous feedback mechanisms: Structured channels allowed teams to raise issues and share insights, which GPOs actively used to refine processes and sustain adoption 

By embedding these success factors, the GPO role became a cornerstone of sustained transformation, ensuring that change was not only delivered but continually reinforced and evolved.  

The success of this transformation was measured in the sustained shift in behaviours, ownership, and mindset across the organisation. Change was grounded in lived experience through Habit Labs, accelerated by sprint-based delivery, and sustained through governance that went beyond compliance to build a culture of continuous improvement, collaboration, and quality. This foundation has already delivered measurable impact, from strengthened inspection readiness to zero critical findings in FDA audits.