This month Rx-360 Board Member, Janice Berger, Senior Director of Global External Sourcing Quality Assurance, AstraZeneca, shares her thoughts on Rx-360 based on her experience working in industry and with the FDA, and what first caught her attention with the organization.
Question: Where did your career in the pharmaceutical industry begin?
Answer: My connections to the pharmaceutical industry began right after college. I received my Bachelor of Science in Biology from McGill University (Montreal, Quebec, Canada) and started off as an investigator with U.S. Food and Drug Administration (FDA). I took some time off during that time to raise my children and then rejoined the FDA and did more work there as a Drug Specialist. I decided to move into industry in 1995 and took a position with DuPont Merck Pharmaceuticals, which became Bristol Myers Squibb. There I focused on establishing a QA Audit program and Compliance. I moved on to Merck & Co. where I served as the Director of Worldwide Auditing for several years. In 2003 I joined AstraZeneca and I currently serve as the Senior Director of Global External Sourcing Quality Assurance.
Question: You’ve had a wide range of experience with ensuring quality, from both sides – regulatory and industry. What about Rx-360 first caught your attention?
Answer: I got involved with Rx-360 at the very beginning in 2009, at the suggestion of one of our leaders, Sharon Bleach – in fact AstraZeneca was one of the founding members of Rx-360. I was interested in the third party audit program. I had done work with these at DuPont and Merck before. I also had the FDA experience with regard to inspections. I had seen the value third party audits and knew this would be a good path to share with other companies. I became a leader for the Rx 360 working group responsible for putting together the third party audit program.
Question: Being with the organization from the beginning, you’ve really seen Rx-360 grow over the past several years. What do you think Rx-360’s top accomplishments have been?
Answer: For me, one of the biggest accomplishments has been the relationship we have built between industry and regulatory agencies. Having industry able to collaborate with regulators is invaluable and necessary to aid in the security of the supply chain for our products.
In addition, I really think Rx-360 has done a great job establishing ourselves as a reliable source of business, compliance and supply chain intelligence. We’re making the public aware of issues. A good example of this is the timely alerts we release regarding emerging issues.
Question: What would you say are Rx-360’s greatest opportunities in the coming years?
Answer: With our audit program, I think we have a greater opportunity to partner with suppliers and show the value of our program – to help them see Rx-360 audits as a valuable tool for them. Now that the program is in place and running, I think we can also work on optimizing the execution of it so that we can ensure it is as cost effective and efficient as possible.
I think another key opportunity in Rx-360 is to continue expanding our organization to include all key stakeholders in the supply chain, namely those involved with procurement and additional regulators. We have a number of procurement professionals that are involved with Rx-360, and we should continue to expand that network. I think it’s important to continue to get endorsement from regulatory groups globally.
Question: What do you find you are most passionate about when it comes to Rx-360?
Answer: Patient safety – that’s what it’s all about! Everything we’re doing at Rx-360 is enabling us to ensure that patients worldwide receive the products they need when they need them and do not have to be concerned about the product’s integrity and quality.
It is a fantastic organization – it provides an opportunity for the pharmaceutical/biotech community to work together to deliver this vision.