From Biochemistry to Compliance

What is the role of a Compliance Lead at Cegeka?
“The role can include a variety of tasks. Over the course of my career, I’ve been involved in several projects, each with different regulations. I started in a more operational role within a team responsible for IT-related validation and change management. With the knowledge I gained, I was able to grow into a more advisory role within a GxP environment. Later, I had the opportunity to deepen my expertise in another set of regulations, namely the Sarbanes-Oxley Act (SOx), and I’m currently serving as a SOx IT Coordinator.”

What inspired you to pursue a career in compliance?
“My studies as an Industrial Engineer in Biochemistry and my previous job sparked my interest in quality within the pharmaceutical industry. As a Quality & Compliance Consultant at Cegeka, I get to combine this focus on quality with the IT aspect, which creates an exciting and rewarding challenge.”

What do you enjoy most about the job?
“What appeals to me most is the variety of tasks: reviewing and approving changes for business updates, monitoring regulations and requirements and making adjustments where needed, being the point of contact for audits, coaching junior colleagues, and more. All of this requires flexibility, but that’s exactly what makes the job so challenging and fulfilling! I also find the interaction with various teams very engaging—working with quality teams, business stakeholders to understand their processes, IT for the more technical aspects, auditors, project teams, etc.”

How do you stay up to date with the latest trends?
“By reading, gathering information through Cegeka, attending trainings, and maintaining contact with various teams at the client.”

What are some challenging situations you encounter in your work?
“Meeting deadlines is always a major challenge. Without a doubt, aside from the deadlines, audits are the most demanding moments of the year. It’s always tense to deliver all the requested information on time, answer all the questions, and, when necessary, defend those questions or discussion points with well-founded arguments. Other challenges in a Compliance role include keeping up with changes in regulations and defining and implementing the required actions. This always involves assessing the risks in what can be a complex environment.”

Which skills do you think are essential for a successful Compliance Lead?
“A sense of urgency, a quality mindset, consistency, efficiency, strong planning abilities, analytical thinking, patience, solid documentation skills, flexibility, and the ability to develop solutions that meet the guidelines while still being workable—all of these are essential.”

Can you give an example of how your work has had a positive impact on a client or project?
“What comes to mind are positive audit results and SOx certification.”

How does Cegeka support your professional growth?
“Cegeka supports my development in several ways. I started with a training program that fully immersed new starters in the GxP framework and validation processes. In my first projects, I was supported by senior colleagues, which really helped my development. Cegeka also offers a range of trainings, including people-focused ones. For my client assignments, I follow more client-specific trainings, as we work in a highly regulated environment. In such an environment, we must always be able to prove that we’ve been trained—especially at the start of a new project, where multiple trainings are required.”

How do you coach your junior colleagues to help them perform at their best?
“I make sure my colleagues have the necessary tools and guidance to understand and follow the entire process. The hands-on experience they gain by first performing the SOx controls themselves helps them see the bigger picture. That way, they can later follow up on the processes at a higher level, make adjustments where needed, and do so in the most efficient way.”

What is your advice for junior colleagues who want to take their careers to the next level?
“My advice to them is to stay open to new challenges and never forget that communication is key—whether in project teams or in the workplace in general.”