PharmaLex

Olena Chervonenko is an experienced pharma quality expert with a career spanning over a decade. She began her career as a chemist analyst and moved to pharmaceutical quality assurance and compliance at Arterium. Chervonenko served as the head of quality assurance regulatory affairs in the pharmacovigilance department of Organosyn for seven years, where she handled business development activities, like managing an entire pharma process from ideation to transferring the product to a contract manufacturing organization and overall management. She is the associate director of quality management and compliance at PharmaLex.

In an interview with Pharma Tech Outlook Europe, Chervonenko highlights the trends and challenges impacting the pharma quality assurance space. She also shares insights for organizations to stay on top of the domain.

What experiences or projects have significantly contributed to your pharma compliance and quality assurance expertise throughout your career?

Two aspects of my previous experience have heavily influenced my current position.

Being the head of quality assurance and regulatory affairs was a global, cross-functional role that helped me understand the whole cycle of a pharmaceutical product and identify and resolve potential gaps and risks.

As I have also handled business development activities, it taught me how partnership with the right people is extremely important. Grabbing the possibilities to understand different people, cultures, and industries is the best way to grow your organization.

What are some of the recurring challenges that you witnessed impacting the industry?

Implementing a culture shift, even something as simple as building a new quality assurance system, can be challenging if there is resistance to change within the organization. A quality culture demands a shift from unproductive behavior ingrained in the organization. 

Another challenge is finding the right employees and partners and gaining their trust so they stay with an organization for a long time. Organizations must develop an internal culture with many possibilities for people to grow so they feel safe to come in and work.

“AI can help different areas of pharma, like data integration, and minimize human errors. However, even with many benefits, it can never replace humans in the industry.”

Are there any technological trends that can resolve these challenges and transform the industry?

An example of a technological trend that transformed the domain is electronic signature, a combination of data analytics, regulatory expertise, and technology. 

A modern and strong data integration system also helps in robust quality assurance practices, which cannot be achieved through paper-based systems.

Organizations should always stay prepared to leverage such technological and regulatory trends. Stay educated on current technologies, including the regulatory aspects like eIDAS or FDA’s part 11 guidelines, set up a team to implement them in the organization, and designate an appropriate budget in advance.

How do you envision the future of pharma compliance and quality assurance?

Artificial intelligence can support the industry in the long run. It won’t be immediate, as the pharmaceutical industry is extremely regulated and controlled. AI implementation can be done if the guidelines are described, and requirements are instilled.

AI can help different areas of pharma, like data integration, and minimize human errors. However, even with many benefits, it can never replace humans in the industry.

What is your advice to aspiring individuals who want to make a mark in the pharma compliance and quality assurance space?

The global pharma industry is constantly changing. Writing a single article cannot prepare you to be part of the industry. Keep learning and be open to evolving with the industry.

Ensure you invest in learning and skill enhancement through good training opportunities. Equally important is staying ahead of market changes to be on top of HR requests. 

The best way to learn is from examples. Converse with your leaders and work collaboratively. Remember that pharma is all about teamwork; we are part of big companies and processes.