We recently chatted with Laura Sieling-Gaylord to learn more about how she came to GCP QA. Trends and challenges she sees in the industry, what brought her to RegDev, and the advice she’d offer to someone starting out in the field.
 

RegDev: Hi Laura! Thanks for joining us. We’d love to hear about your journey in pharmaceutical consulting. Can you tell us a little about your background and how you got into the field? 

Laura: I was introduced to the pharmaceutical industry through my dad, an R&D microbiologist. I spent three years in Regulatory Affairs before moving to Clinical Quality Assurance (CQA), and I’d never go back because I love traveling for audits and inspection readiness projects! With RegDev, I have enjoyed expanding my CV to include Computer Systems Validation, developing client training programs, and participating in regulatory agency Inspections.

RegDev: What were your main considerations when you decided to join RegDev? 

Laura: I had already worked with Sid and a team of RegDev consultants as a client at a different company. When I saw how well they integrated themselves into our team and how effective their feedback was, I became interested in becoming a consultant.  

Now, the most exciting thing about working for RegDev is how many different projects I get to work on! I can work with a client who needs a routine investigational site audit as well as a client experiencing a Regulatory Agency Inspection. There’s no way that I would get this varied experience by only working for a traditional pharma company! 

“With growing uncertainty in the government, RegDev offers a stable understanding of the pharmaceutical industry. With so many years of collective experience, our consultants are able to support clients who may feel overwhelmed by changing guidance and regulations.” 

RegDev: What are common pain points you see in the industry? 

Laura: A common pain point in this industry is integrating risk-based decisions across functional areas. With increasing focus on this approach to clinical development, it is crucial for companies to take an early, holistic approach to risk assessment.  

For example, RegDev can support a client’s development of a Clinical Monitoring Plan that takes into consideration the seriousness of each data point captured by an EDC system to ensure appropriate protection and handling of participant data while also avoiding unnecessary burden on Data Management, CQA, site staff, etc. 

RegDev: How can RegDev make a difference in the industry or in this particular specialty space?

Laura: With growing uncertainty in the government, RegDev offers a stable understanding of the pharmaceutical industry. With so many years of collective experience, our consultants are able to support clients who may feel overwhelmed by changing guidance and regulations.  

“It is crucial for companies to take an early, holistic approach to risk assessment.”

RegDev: What are some notable or memorable projects you’ve worked on that you feel most proud of? 

Laura: I am most proud of leading clients through Inspection Readiness and Regulatory Inspections. So far, every client that I’ve worked with on these activities has had a product approved! This is the most rewarding kind of project because of how many patients are positively impacted by the products that make it to market.
 

RegDev: What has been one of the most positive experiences in your role? 

Laura: My favorite memory of working in CQA was a three-week trip that I took with my colleagues to Italy, France, and Belgium to conduct multiple investigational site audits. We worked hard (and ate great food!) and I became a significantly better auditor from their guidance.

RegDev: What’s the one piece of advice you would give to someone starting out in the pharma/ biotech/ life sciences industry? 

Laura: You can learn so much on the job! Don’t feel like you have to enter this industry knowing everything or necessarily having a technical degree (like RA or biology or nursing). I was extremely intimidated when I started my first job in RA, but by asking questions, researching in my spare time, attending free Regulatory Agency meetings and conferences, and making connections with coworkers. I have gained the knowledge to be a confident extension of any client team that I’m assigned to. It’s a wonderfully dynamic and challenging job, and I encourage anyone interested in making an impact on patient health to give it a try!