‘An individual who realizes opportunities and crafts pioneering works of art out of them’ is the definition of a CEO. A beacon of inspiration, an amicable coworker, and the enthusiasm to be the torch-bearer of an organization’s vision, are the evident traits of a complete leader. Similarly, Gregory W. Pierce, the CEO of EngiLifeSciences, has been a frontrunner in developing solutions that allow Medical Device, Pharmaceutical and Biotechnology Manufacturers to efficiently bring compliant and high-quality products to market.
During his 28 years of experience, he has worked across the Healthcare Value Chain with high profile companies such as Ethicon Endo-Surgery, Abbott Laboratories, Cardinal Health, and the United States Air Force. He continually innovates and customizes value added solutions for Product Development, Supplier Management, Manufacturing, Quality Systems, Regulatory Compliance, and Information Technology.
He avidly participates on industry initiatives collaborating with FDA, Industry Representatives and Universities on Artificial Intelligence, and Product Quality Metrics within the Healthcare Industry. His extensive and comprehensive educational background includes an M.S. in Computer Science/Distributed Systems as well as an MBA in Computer Resources/Information Management. He also holds a B.A. in Organizational Management and an A.S. in Medical Lab Technology.
An Industry Pioneer
EngiLifeSciences is a consulting firm and provides services across the healthcare value chain. The company’s consulting solutions are funneled towards Quality Systems, Product Development, Manufacturing, Information Technology, Regulatory Compliance, Software Compliance, Software Technology, Computer Systems Validation, and Quality & Business Performance. It offers an array of services that are targeted at increasing the bottom line for an organization.
One of the visions of EngiLifeSciences is to be a transformational agent in the life sciences industry, bringing more innovative approaches to organizations and impacting the internal processes. It helps organizations in keep pace with the rapidly changing regulatory ecosystem and become more agile so as to attune faster to the external conditions in the market.
The company’s mission is to transform the Healthcare Value chain by creating end-to-end visibility, driving the highest-level product quality and improving business performance to stimulate innovation, ultimately helping save more patient lives.
In the quality systems area, EngiLifeSciences helps with process improvement including compliance. Addressing the regulatory concerns and issues, we assist our clients in transforming their processes to a compliant state and also help in remediation of various areas of the quality systems.
When it comes to quality and business performance, the organization focuses on manufacturing, product development, information technology, quality systems, and how these processes can integrate to offer end-to-end visibility, helping organizations identify opportunities.
Gregory’s Career started in the United States Air Force working within the military hospitals as a Medical Laboratory Technologist and then transitioned to working in Research and Development for a major Medical Device Manufacturer; in the development of technology which falls in the category of Digital Health, and later in working for corporate America in the development of new technology medical products.
“The pivotal point for me was when I decided to start my own company helping companies in the medical device, pharmaceutical and Biotechnology industry,” states Gregory.
A Challenge-Driven Position
Over the last 28 years, Gregory has observed that corporate culture is the greatest barrier for innovation. He asserts “Corporate Culture has become one of those buzz words that is apparently very difficult to attain, yet of primary importance to succeed. I believe that cultural change starts by changing current behaviors.”
He also adds that for any CEO, breaking the paradigm, ‘that’s the way we have always done it,’ which reveals that traditional work methods which add up to the challenges involved in the designation. According to him, taking an open and honest view about operational processes and involving everyone in eliminating all non-value-added steps in those processes while reinforcing and creating value-added activities, can aid CEOs in working efficiently.
Gregory comments, “Allowing ‘common sense’ practices to drive our behavior and involving the organization in that change, develops a culture of ownership and accountability which opens the door to innovation and increased visibility.”
For Gregory, striving to provide highest quality of service for his clients has been the biggest challenge. He recalls a significant project which involved helping a client in remediating Quality system for Software Validation from Product Development, Manufacturing and IT Enterprise in addition to remediating all the software systems which had regulatory implications. The program had aggressive timelines with a tremendous effort required in a short amount of time. “This program was one of those when looking at it appears to be impossible to meet the time commitments,” states Gregory.
“However, working with the team and watching them grind through all the challenges one by one, and when we all met the time lines and quality required to pass the horizontal and vertical audits first time really, drove positive feeling in accomplishing something that almost looked impossible within the constraints we had,” he adds while expressing his contentment towards the efforts of his team.
Beholding a Triumphant Future
According to Gregory, technology and digital health is expanding at an accelerated rate, including the use of artificial intelligence and other technology solutions to bring value to the healthcare. With EngiLifeSciences’ relevance to this expansion, he asserts, “For us to be an accelerator in the healthcare value chain, bringing more innovative approaches to organizations, and impacting internal processes resulting in agility and innovation is necessary.”
Gregory’s advices the aspiring CEOs by stating, “The keys are Focus and Persistence, never give up, no matter how difficult it becomes to pursue your dreams.”