Our Success Stories As Told By Our Clients

shelly ogiste AGTC

"It had been challenging to find a Quality consultant who understood GCP/GMP/GLP regulations, was flexible, and able to understand our company and our progression. From my first conversation with Judy though, it was clear she would make a significant impact. And she is by helping us build an outstanding and solid Quality Management System.

“She first met with key leaders to gauge the Quality culture. She also conducted a thorough review and gap assessment of our facilities and systems. There were many improvements to be made, but she took the time to fully understand our people, our challenges and our existing company culture before presenting us with an Quality Improvement Plan with prioritized goals and objectives. The plan was reasonable, impactful and rooted on responsibility and accountability. There was a lot of work to be done! But Judy was there every step of the way, supporting us with the tools, training and education needed to successfully execute each goal.

“Judy is passionate, responsive, and knowledgeable in all aspects of the drug lifecycle from beginning to end. She fully understands GCP/GMP/GLP requirements, is quick-minded, can untangle issues, and can get to root causes quickly. As a partner, she is flexible in her approach so that our people feel part of the process, while making sure that we comply—and that people understand how it all works together and how it is applicable to their role.”

Shelly Ogiste
Director of Quality Assurance
AGTC, a clinical-stage biotechnology company
that uses a proprietary gene therapy platform
to develop transformational genetic therapies
for rare and debilitating diseases



“Judy is a great Quality lead for any start-up life sciences company. There are many traits that make her a great fit, including a high level of integrity, approachability, consensus-building skills, and flexibility. She is committed to implementing a robust internal QMS for Quad and educating our people appropriately.

“Judy’s deep knowledge of Quality along with her broader understanding of the operational side of our business makes her more effective as a Quality leader. She thinks like an executive. She has implemented Quality requirements that do not inhibit innovation or product development, but add strategic value.

“I highly recommend Judy because she understands how companies can think about and integrate Quality early on. Her approach and mindset helped make Quality a core element of our business and our company culture.”

Sean Kevlahan, Ph.D.
Chief Executive Officer and Co-founder
Quad Technologies


"Dr. Carmody is knowledgeable, passionate and personable with strong soft skills that allow her to navigate the specific quirks of any complex biotechnology organization.

"When I first joined in 2015 and conducted a required review of our standard operating procedures (SOPs), I found we needed critical revisions to approximately 25 Good Clinical Practice (GCP) and safety SOPs. And we needed to create additional SOPs to enhance accountability, quality and process control.

"When considering candidates for this project, Dr. Carmody’s intimate understanding of the issues stood out. She demonstrated she could hit the ground running with minimal oversight, and see the project through to completion. She shared my understanding of how SOPs should be built and structured, since they are vital to how we drive the business and execute GCP, so we can deliver innovative cancer therapies to patients.

"I highly recommend Dr. Carmody based on her track record with us. She has strong industry knowledge, a high level of competency with GCP Best Practices, and a wonderful collaborative approach to working with and managing multiple shareholders."

Marissa Volpe
Executive Director, Clinical Operations, ImmunoGen, Inc.

AndrewBall Quad

“We recognized that our products for research use also had applications in regulated markets requiring GMP manufacturing. This necessitated more stringent quality requirements and controls. We needed a Quality Lead to help define those requirements and implement a quality management system. From an R&D perspective, there can be a perception that QA, while a necessary resource, can be an obstacle, slowing down development. But with Judy, it was quite the opposite.

“She has been extremely collaborative and helpful in accelerating our GMP product development timeline. She helped us clearly define our needs and implement the required standards for cGMP manufacturing, including, to name a few, processes for setting specifications, dispositioning batches, transferring methods, performing investigations, and implementing CAPAs.

“She has a strong understanding of our process and the science—both the chemistry and the biology of what we are trying to do. Judy helped us hone in on critical needs for analytical assays to qualify materials, and where to best invest resources for external contract testing, which can be expensive.

“The bottom line is that her approach and views on Quality helped us accelerate timelines for GMP product development. And, in a rarity for this industry based on my experience, a collaborative relationship exists between R&D and Quality. It really comes down to a combination of Judy’s knowledge and willingness to work in partnership to achieve goals. I can’t speak highly enough of her.”

Andrew Ball, Ph.D.
Vice President of Research and Development
Quad Technologies

Ackley“If there is one word to describe Dr. Carmody, it is competency. Her extensive skills and background in oligonucleotide analysis helped Avecia quickly bring a new lab online. The new lab allowed us to increase our analytical services capacity and better meet the demands of our clients.

Judy is decidedly effective for three reasons: Firstly, she knows Quality Assurance/Control Services and cGMP intimately. She continually demonstrates an extreme commitment to Quality and drives complex activities to completion with minimal direction. Finally, she provides unique strategic insight gained from managing her own FDA-registered contract research/manufacturing organization. These reasons allow her to provide exceptional analytical and operational value.

Judy is a highly competent, knowledgeable resource. Any biotechnology firm will be fortunate to have her leading their QA/QC and analytical development efforts.”

Kathryn L. Ackley, Ph.D., RAC
Vice President of Development, Nitto Denko Avecia Inc.


"If I had to describe Dr. Carmody in a word, it would be trustworthy. Judy has been the best resource to offer strategic value and insight, as well as produce tactical deliverables within rapid turnaround times.

Judy has seen it all; she has the GCP experience to develop systems, including CAPA processes and SOPs. She was helpful with a recent client audit and guided us on which primary areas to focus on. She supported efforts to develop the QA infrastructure we needed, which included business continuity and IT disaster recovery plans. Not only does she meet GCPs goals, she surpasses them—she offers a level of scientific Quality that is impressive.

She has helped us bring our QA department to the next level. I would highly recommend her; her multi-disciplined approach and broad knowledge base—from GMP and GCP for biotech and pharma—makes her a major asset to any CRO.”

Caroline Duque
Manager, Quality Assurance, Analgesic Solutions

© 2020 Build Quality Cultures in Pharma and Biopharma with Carmody QS. All Rights Reserved.