Paul has been with Owen Mumford for over seven years and leads both the Regulatory functions and the Quality department. He’s a member of the Owen Mumford executive board and has played a vital role in helping the business adapt during the current pandemic. We were excited to discuss his main responsibilities and thoughts on the future of Owen Mumford Pharmaceutical Services!
What changes have you had to make in your position in recent months due to the pandemic?
The biggest change I’ve had to make over the last couple of months was enabling as many of my team members as possible to work from home—both for their safety and to protect those who needed to be on site to keep our business running smoothly. It was also a challenge making sure our Quality Management System (QMS) stayed effective to support the rapid changes happening in the business. Thanks to a fantastic team, a little flexibility, and creative solutions, we have succeeded in getting a large majority of the team working from home while maintaining the GMP standards that are crucial for our range of drug delivery and diagnostic products.
We even managed to complete the first part of our Notified Body MDSAP surveillance audit remotely using different technology, and it went very well.
What are some of the main activities you’re working on now that will benefit our customers?
Our main activity to help customers is making sure our products are top quality and work as they’re supposed to when needed—this matches our Quality Policy, which is all about making our customers happy.
This is an exciting time for quality and regulatory affairs in our industry, with the Medical Device Regulation (2017/745 (MDR) coming into effect, even though it’s been delayed a year—we were well prepared and ready if it had come into force this year. We’re also using this as a chance to review how we operate, so we can support our operations, R&D, and sales teams more efficiently and deliver both new and existing drug delivery and diagnostic products to customers.
We’re always reviewing and challenging how strong our QMS is (which is key to making sure we’re compliant and delivering products to the highest possible standards). Right now, we’re focusing on making our processes as efficient as possible (like focusing on risk management, post-market surveillance, and design controls), updating our tools, and ensuring our system meets best practices.
What excites you most about the future for Owen Mumford Pharmaceutical Services?
The new products in development, such as safety syringes, and the ideas we’re exploring at the feasibility stage are really exciting. They present all kinds of new opportunities and challenges—the best part is seeing how they build on the core strengths Owen Mumford is known for, like auto injectors, but also expand what we can offer. One of the most rewarding things is seeing new customers come on board, or seeing current customers open up new opportunities for us to partner and learn from each other.
The upcoming product platforms for safety syringes and auto injectors will bring many opportunities for Owen Mumford. They enable us to offer our expertise in new ways and, through these new products and Owen Mumford Pharmaceutical Services, show what Owen Mumford is all about. It’s truly exciting to have the chance to make a real difference for patients.