How to Give Quality Assurance the Respect It Deserves During a Post-Merger Integration

A typical post-merger integration (PMI) between two companies is challenging, time-consuming, stressful, and resource intensive. Even the companies most experienced with integration find these activities demanding.   

But this complexity is further intensified for small/mid-sized companies that do this activity infrequently or for individual functions (e.g., Clinical Development, Quality Assurance (QA), Commercial) that will now have duplicate processes/roles/technology and unique legacy processes/roles/technology to resolve as a result of the integration. These individual functions will have to execute a PMI within a defined timeframe while also continuing their ongoing activities.

Typically, the desired result of this PMI is that the company will realize financial, productivity, efficiency, and organizational goals, while realizing synergies and minimizing redundancies. These drivers exist regardless of organizational size, geographic footprint, function, type of company, or portfolio size. One can argue that the larger the company, the more difficult the integration. But, if a function does not have the adequate integration infrastructure or if a smaller/mid-sized company rarely goes through acquisitions, then the level of challenge is just as high for those groups as well.

What is the PMI situation for a QA organization?

Irrespective of the company, QA often seems to be the under-appreciated and lower prioritized function in life sciences PMI activities, even though they are critical for assuring quality and assessing compliance to global regulations and applicable quality, drug stability, and safety standards. As such, PMI for QA groups is often a hodgepodge of generic PMI approaches and support that lacks the full complement of QA expertise and understanding. QA resources are also asked to work two jobs simultaneously – their daily work and significant roles on integration teams. The level of support and attention needed by QA rarely reaches the rigor, prominence, investment, and customization level seen by Commercial or Clinical Development organizations.

This type of PMI support is not what a QA organization needs or deserves.

The work of QA is foundational for every life sciences company, which, in turn, serves the patient community. QA should have a structured PMI strategy and approach that has the foundation of core PMI concepts, but is built for Quality Assurance. The PMI strategy and approach should, for example, understand the core elements of a Quality Management System, the underpinning regulations and standards, the challenges of integrating QA processes, and the cross-functional relationships that QA has with the rest of the organization. These core themes can form the basis of a PMI methodology that can specifically help QA organizations achieve their financial, productivity, efficiency, and organizational goals.

Below we provide five recommendations to help ensure PMI success for a QA organization:

Develop a "Fit-For-Purpose" PMI Methodology

PMI is very difficult given the complexity, time constraints, resource impacts, and desired outcomes. Given the investment for the acquisition, it is critical to apply a level of investment commensurate with the importance of QA to the organization. Some considerations to ensure a fit-for-purpose PMI methodology are:

1. Be realistic about the capabilities of your team to effectively and efficiently drive a PMI. Re-allocate individuals to solely focus on the PMI for a defined period of time and utilize third party support who has actual experience in conducting PMIs for QA organizations.
2. Ensure there is a methodology and approach for executing the PMI and this is not "make it up as you go."
3. Understand senior level commitments and utilize that to build an achievable and realistic implementation plan for integration; and
4. Be agile. Several unplanned challenges and issues will arise, and the need for the PMI team to be focused on achieving their goals while being agile and flexible will be important.

Confirm the PMI Team understands core QA Fundamentals

QA is built upon several global regulations, standards, and core QMS concepts (e.g., GxP, CAPA, Quality Risk Management, Change Management and Computer Systems Validation), and an integration team with a clear understanding of these concepts and awareness of complexity will be essential to successfully building and executing a PMI strategy. This team should be able to rapidly assess, determine a path forward for the future state, and identify synergies and potential challenges while evaluating the differences in models between legacy organizations. Without a solid background in this area, the QA Team will need to prioritize their limited time explaining QA basics to the PMI project managers over driving to outcomes.

Define a Future State that meets the needs of both QA groups

Building upon the understanding of QA fundamentals, the ability to drive towards building a future state for the areas within QA will be important. Determining items such as mission, vision, strategic goals, impacted processes, technology, roles, and stakeholder dependencies will be important in creating the elements of the integrated organization and facilitating buy-in from the appropriate stakeholders within the organization. Finally, addressing those finer details of how the integrated organization will achieve compliance (e.g., terminology, different scoring criteria, titles, issue escalation processes) and coming to compromise solutions will be the activities that ensure that these future processes will serve a solid foundation for the combined organization.

Bridge the Cultural Divide between legacy organizations

Once the future state of the integrated organization is determined, bridging the cultural divide between the legacy organizations will be essential for integration success. Typically, the integration team is so focused on achieving the primary goal of defining and achieving the future state, culture is often overlooked or underserved. Examples of items to consider are:

1. Impact of geography on the future state;
2. How the legacy QA organizations collaborate and work with their current stakeholders (in and out of QA);
3. Risk tolerance practiced in legacy organizations when determining how to comply to regulation;
4. Supplier and/or Third Party Partners – Landscape of partnerships and collaboration and management of strategies/processes; and
5. The institutional comfort and mechanism for which the legacy QA organizations interact with global regulatory bodies.

Prioritize people throughout the process

When executing the PMI, the work is so complex, change impacts are significant, and the pressure is so high, that forgetting your people or having an under-developed people strategy is quite possible. People are the organizational memory and one of the reasons why the QA organization performs as it does. Some considerations in developing and executing the people strategy are:

1. Determining a strategy to identify and keep the highest performers;
2. Keeping an eye on unmanaged attrition of the overall workforce;
3. Identifying and retaining individuals who have strong regulatory body relationships;
4. Finding ways to keep morale high during this time of significant change; and
5. Identifying individuals who are successful in collaborating with impacted stakeholders outside of QA (but within the company). The unexpected loss of this high-performing talent can have negative financial impacts due to recruiting, retraining, and process execution impacts.

Keeping these and other considerations in mind are important for executing a strong people strategy for your PMI.

Post-Merger Integration for Quality Assurance

PMI activities are highly challenging, but when done correctly, they can be rewarding from a strategic, operational, financial, and people-based perspective. Executing a PMI for a Quality Assurance group is even more challenging due to the need to understand and build the unique needs of QA into the PMI strategy. Without that inclusion, the ability to give QA a properly constructed PMI program that meets its needs will be significantly hindered, leading to suboptimal outcomes. Balancing the financial investment of the acquisition and the importance of QA to the R&D value chain, the company, and the patient population, a strong post-merger QA organization positioned for success should be the goal for any QA-related PMI team.