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Managing change process: How quality professionals become change leaders


What is Change Management?

In order to keep up with rampant globalization, manufacturers face ever-increasing pressure to produce high-quality products faster and at lower costs. They continuously need to respond quickly to meet evolving customer demands and comply with new regulations. In other words, manufacturers in highly regulated sectors such as the life sciences are in a state of near-constant change. Organizations in these regulated industries must therefore continuously control and manage these changes to their processes.

Change control  (also known as Change Management) is a crucial element of any Quality Management System (QMS) process in highly regulated industries such as the life sciences and must be integrated into the manufacturing process. The word "change" in manufacturing refers to any modification to equipment, manufacturing materials, facilities, utilities, design,  allow formulations, processes, packaging/labeling, systems or computerized systems, and any associated documentation, such as SOPs, quality manuals, etc. For more details about the change management process in the life sciences, head over to our definition of change control management in the Scilife glossary.

A change might affect the validated status of facilities, systems, equipment, or processes. Therefore, change should be conducted and documented systematically by a multidisciplinary team in order to prevent undesirable consequences. A solution should be created based on the needs, regulations, budgets, and an action plan for the change. Change management is ultimately controlled and conducted by a change leader

In this guide, we cover the main change management challenges, the solutions to these obstacles, and our own expert advice on how to become a change leader in regulated industries like the life sciences. Soon, you and your team will be able to breeze through organization-wide change and carry on your journey of continuous improvement!


Overcome change management challenges and become a great change leader!


1. Develop leadership skills

The first hurdle in any change control process is to get a good team organized, to delegate who will be responsible for what, and to seek ongoing support from management. Successful company-wide change management requires the full dedication, involvement, and regular communication of all employees from all levels of an organization. Organizing the right team therefore also means overcoming the perpetual challenge of regularly motivating everyone to remain fully engaged. That doesn’t just refer to the employees in the change team, it also applies to management. Often, the biggest roadblock to successful change - and why a change management process fails to accomplish its goals - is a lack of support from managers as well as employee resistance.


To be the head of a successful team, a change leader must possess the leadership skills to get and keep everyone on board, both employees and management. 


To be the head of a successful team, a change leader must possess the leadership skills to get and keep everyone on board, both employees and management. 

A successful change leader needs to have the following essential leadership skills to overcome challenges that might occur during the change processes:


    • Communication

To truly drive a team forward, a  change leader should be an excellent communicator. They must be able to communicate a compelling business case for change and a clear call to action throughout the organization. The change should be aligned with the organization’s vision, values, and strategic plan. A change leader should communicate clearly and frequently and should understand strategy. They should take charge and monitor the action plans and key metrics that are cascaded to each department and individual. Change progress should be consistently measured and frequently reported against established goals.


    • Facilitation

The ideal change leader should be a natural facilitator, be influential, and possess excellent collaboration skills to boost support for the change, remove obstacles, and reduce resistance to change. A change leader is responsible for determining the key stakeholders and influencers since their collaboration is critical to gain the support needed to achieve the set goals and ultimately succeed in the change.


    • Project management

A good change leader is organized, and experienced in project management. They will need to be able to organize the resources and competencies which are needed to support the change project, adapt to challenges, and keep the change project on schedule and within budget. A change leader is responsible for creating a formal action plan based on an agreed change strategy that incorporates all the methods, tools, and technical assistance to lead everyone involved through change. In addition to generating an effective change control action plan, it’s important to track project health in each step and evaluate change management efforts regularly. 


    • Collaboration

An effective change leader is both a collaborator as well as a motivator, and is deeply involved with the project as well as having the skills to get everyone on board to make decisions, plan, and execute. A change leader should be a role model for the team and encourage all employees to be innovative and creative by providing the necessary tools, a space without criticism, and an environment where ideas are shared openly.  This way, a change leader makes their team feel as if they’re an integral part of the process and it bolsters everyone's sense of pride. A positive attitude always motivates a team, and a sense of belonging to an organization is a surefire way to inspire loyalty. 


    • Commitment

A successful change leader shows their commitment to the change, the team, and maintains control over the whole process. This means continuously identifying and focusing on priorities. A positive attitude of commitment becomes an example and influences the rest of the team, ultimately driving the success of the change project. A positive and encouraging leader means less resistance to the change process. 


Take-home messages for any inspiring change leader: 

    • Leading a change is never a one-man job. Invest in your team!

    • Believe in yourself but also believe in your team.

    • Never stop motivating your team!

    • Influence your team by being a role model

    • Don’t be afraid to assign responsibilities to other leaders in the group


More on the Scilife blog

Change Management: 7 steps to a streamlined transition



2. Sidestep Resistance

Change is hard only because maintaining the status quo is easier. Doing things even a little differently requires cognitive energy! Because most people are busy, there should be a clear payoff to invest that extra energy in changing, even if the change seems simple.

To become a successful change leader means supporting and convincing the team why the change is crucial, why they should invest their time and energy, and what would be the benefits (both for them and the organization) after implementation. 

Possible causes for resistance:

    1. A system is not user-friendly (users likely to resist).

    2. The costs outweigh the benefits (management likely to resist).

    3. Change is proposed ‘from above’ without consulting the team (employees likely to resist).

    4. The change doesn’t seem technically necessary - If there are strong (technical) reasons why a change is needed, and the change is rationalized in a technical way, resistance is unlikely.


Avoiding resistance before it happens:

    1. Bring in executive support and active sponsorship.

    2. Involve users in the design process (co-creation).

    3. Explain the change benefits to gain the change management buy-in from everyone



3. Co-Create with your team

If you want your change management project to progress without resistance and for everyone to contribute to the change, then you should make your whole team feel like part of the project and give them the freedom to suggest actions and develop solutions.

Ask your team and users about their needs and suggestions before embarking upon a change in order to co-create a solution. Define the goals only to allow the team to come up with solutions and contribute to the change. If you co-create a solution with your team, you’ll have engaged and enthusiastic employees instead of resistance. 


4. Communicate and listen

A successful change leader should possess strong communication skills, but must also listen to their team very carefully.  If you encourage detailed feedback from your team, both negative and positive, you’ll be one step ahead of potential resistance and can improve the change management process. 

It’s important to involve all necessary employees, management, and even users in the first meeting about the change.  Start with explaining how they tie into the long-term vision of the organization. All strategies should be communicated according to how they support and integrate with that vision.  Provide answers to the questions below so everyone is on the same page:

    • Why does your organization need the change? 

    • Which goals does your organization aim to achieve after the implementation of this change?

    • What are the possible solutions for that change?

    • What are the benefits that change can have for the organization, and the whole group?

Support for change management is much more likely when the benefits of the activity can be clearly identified and contextualized for everyone involved. If change management is presented as simply a list of activities or new processes that will be implemented (increased communication plans, ongoing assessments, etc.), then change management might be seen as increased activities and more work that will complicate daily outputs. Open communication helps everyone gain trust. Similar to the co-creating logic, it’s essential to maintain constant communication through the change. Involve everyone in each step of the process, and don’t forget to check if the communication is actually working by asking for feedback.

To become a true change leader, in addition to communicating well, try to incorporate an understanding of what weaknesses of previous practices are addressed by this new communication strategy. Show your team that you’ve learned from the past and are attempting to make the change effort more successful this time. 


5. Keep it simple

Although superior change leadership is fundamental for the success of a change, the change project should be as simple as possible. If you focus too much on perfection, it could be resisted by others as a complexity that’s not easily understandable or doable. Most of the time, defining actions and addressing goals in a way that’s clear for everyone is fundamental to avoid resistance. 


6. Be patient about new methods

New or better management methods are great, in theory!  However,  getting your team to embrace these methods is a whole other story. People usually don’t like to use new or better methods, instead preferring to do it the same way they’ve always done it. It’s human nature to go for what’s safer and easier. Unfortunately, that's usually a missed opportunity to grow and improve. 

Rather than getting frustrated about that, it’s more productive for a change leader to listen to their team, be sensitive about their feelings, and try to foster a culture that embraces change as something positive for everyone. Be patient about the process and let people get on board in their own time.


7. Stay on the Pulse

A change leader doesn’t just generate an action plan, but monitors and measures that plan continuously during the change process. That means making improvements and strategy adjustments in real-time. Additionally, to understand the overall performance of the project, it’s necessary to monitor ongoing project health regularly. That helps your team to determine weak points and improve them quickly. Setting up correct measurement strategies is therefore essential to enable you to monitor progress and achieve goals. 

Change management efforts should also be evaluated. Performing a Prosci Change Management Maturity Audit can enable an organization to determine current strengths and weaknesses, and allow for an ongoing strategy for improvement to be designed.


8. Evaluate how it went & where you can improve

Finally, it’s really important to evaluate how the change and your team performed after implementation. Using a Deming Cycle, also known as a PDCA model (Plan, Do, Check, Act) is an extremely beneficial tool for this, and is often overlooked. This final review step helps power the cycle of continuous improvement.

More on the Scilife blog

How to Implement the Continuous Improvement Cycle in Regulated Industries



Streamline change management
with Scilife

If you’ve got this far, you’ve already taken a big step to becoming a better change leader! Now you can go on to develop and polish those leadership skills, evaluate and remove possible points of resistance, co-create a solution with your team, communicate frequently, listen constantly, be patient when implementing new methods, keep things as simple as possible, monitor and analyze fastidiously, and evaluate once a change plan is carried through to completion to learn valuable lessons for the next change.

As you’ve discovered, a superior change leader takes on a lot of responsibility and duties. Careful change control management transforms resistance into acceptance. Thankfully, Scilife makes change management a breeze through our dedicated Change Control module!

Our Change Control module provides a structured and clear path for change requests, approvals, and implementation of modifications.That empowers your whole company to participate in changes. Integrations and smooth workflows remove obstacles that might lead to resistance and allows everyone to embrace change fully.


Try Scilife’s Change Control module today!



The requirements of Life Sciences companies (including in the pharma and medical device space) inevitably change over time. Sometimes, a change is due to regulatory requirements; sometimes, customer needs change. Keep reading if you want to...