“I rely on Karen to provide me with an independent assessment and interpretation on current regulations. She does this in an excellent capacity through her thorough understanding and experience of Quality System Management and her observations of multiple client’s Quality challenges. In addition to Karen’s extensive knowledge of Quality it is her personality and the way she explains her rationale that compels people to change their behavior and help with the implementation of an effective Quality System and continues improvement.
It is with her help that we have turned the Quality System around and created a system that has been audited by Regulatory Agencies as well as at least 15 customers during the past two years, with no major observation.”
Director, Quality Assurance
“Karen has an exceptional collaborative approach in supporting her clients, along with her knowledge and expertise. Karen provided immediate pragmatic focus and guidance to areas with improvement opportunities within our QMS. This preparation enabled constructive and positive discussions during an ISO audit. Karen is quick to respond to inquiries for assistance and I look forward to our continued partnership.”
Quality Systems Manager
Cell Signaling Technology, Inc.
“Karen has been a collaborative and trusted partner as we continue to develop and improve our quality management system. She provides extensive expertise as well as a practical approach to implementation of quality related policies and procedures. Most importantly, Karen is able to effectively work with individuals at all levels across all departments and she consistently delivers to her commitments.”
Joanne Spadoro, Ph.D.
Chief Operations Officer
T2 Biosystems, Inc.
“Karen Iorio brings a pragmatic approach to defining processes, controls, reporting and monitoring, and she is always a team player. I never hesitate to recommend Karen. She is a highly respected and talented executive.
I have worked with Karen Iorio in two very different settings: First at Picis, a tech company that automated the high acuity areas of the hospital. With over 1,800 large hospitals as clients, we needed to have a strong, comprehensive understanding of all relevant regulatory guidelines, and we needed to instill a culture of quality and compliance. Karen worked collaboratively with our line executives to define and develop our Quality Management System (QMS). She demonstrated the ability to be the expert and yet still involve all stakeholders in defining a flexible process that could accommodate the overhead structure we could afford and be compliant with FDA and other global regulations.
I subsequently hired Karen as a consultant to N-of-One. We provide the clinical interpretation of next generation sequencing results along with other molecular diagnostic testing. We needed a comprehensive QMS to position us for growth and to ensure quality and compliance during a period of rapid expansion. Once again, Karen accomplished the job with efficient expertise. We continue to work with Karen to evolve our QMS to meet new client requirements and to stay abreast of the regulatory landscape in both the US and internationally where we are doing business.”
Christine M. Cournoyer
N-of-One Therapeutics, Inc.
“Karen is an attentive professional and solid team player. She has responded well to our evolving needs as a startup through good communication and realistic expectation setting. I have full confidence in her in getting the job done and meeting our timelines.”
COO and Founder
“Karen quickly and accurately did an independent assessment of our QA program and put us in the correct direction. Her assistance was invaluable to us. I would be happy to recommend her at any time.”
Michael F. Nolan
President, Chief Operating Officer