About Our People
About Judy Carmody, Ph.D.
Judy Carmody, Ph.D., is the founder and Principal Consultant of Carmody Quality Solutions, LLC (CQS). Scientific understanding and collaboration underscore her unique approach to solving a myriad of challenging Quality issues. With 20+ years of specific expertise driving vision in operations, Quality assurance, control, systems, validation and analytical development, she has a reputation as a Quality Turnaround Specialist in the pharmaceutical and biotechnology industries.
With expertise in applied technology, bench chemistry, validation, Quality management and leadership, Judy leverages the creative integration of technologies from diverse fields and enables these elements to be transformed into client solutions. She consistently enhances Quality cultures through positive and influential relationship building, resulting in greater corporate compliance with Quality systems and regulatory requirements. She demonstrates a consistent ability to increase profits and ensure GxP compliance by quickly identifying and reducing inefficiencies, as well as analyzing and focusing on outcomes of key performance indicators and metrics.
Prior to CQS, Judy held Quality leadership positions at several pharma/biopharma companies where she established corporate Quality culture and provided Quality oversight of internal and external operations. She built Quality management systems for both start-up and Fortune 500 companies, which have undergone multiple FDA inspections with no FDA-483s issued.
Previously, she was the Director of CMC and QbD at Vertex Pharmaceuticals where she established and maintained the Commercial QC laboratory and associated Quality Systems. She led the development of a commercial Quality control laboratory that played a critical role in the successful launch of Incivek®. Prior to Vertex, Judy founded Avatar Pharmaceutical Services, an FDA-registered contract research organization that provided Quality, submission-ready customized analytical services in compliance with cGMP. Judy grew Avatar to 25+ employees and over 75 clients before it was purchased by Vertex in 2010. She established and enhanced the Quality Systems resulting in no critical or major findings while simultaneously expanding service offerings to include downstream purification/manufacturing of a protein intermediate.
Dr. Carmody holds a Ph.D. in Analytical Chemistry from Clark University in Worcester, Massachusetts.
About David J. Innamorati
David is a Senior Consultant, Technical Development at Carmody Quality Solutions, LLC (CQS), where he provides strategic and tactical solutions for the scientific and technical facets of clients’ drug development programs. With 20 years of compliance expertise in commercial and clinical manufacturing, David’s focus is QC/QA, investigations, risk management, CAPAs, validation, continuous process improvement, and analytical development.
Previously, David was at Alexion Pharmaceuticals, a company focused on developing drugs for rare diseases. While in manufacturing, David was responsible for compliance activities, including deviations/investigations across all functional areas, clinical phase change management, continuous improvement initiatives, and inspection readiness. While working in the QC Chemistry group, he was responsible for method transfer, QC testing, training, investigations, and annual reporting.
Before Alexion, David was Principal Scientist at Avatar Pharmaceutical Services, a cGMP contract lab that specialized in biopharmaceutical therapeutics analysis. As the lead scientist, he developed IQ/OQ/PQ documents, standard operating procedures, and validation protocols. He established analytical methods for UPLC-MS/UPLC/GC/CGE/HPLC applications and performed analytical assays (HPLC, UV-VIS, Thermal Melt, Osmolality, pH, CGE, Amino Acid Analysis). He also trained lab personnel to perform all standard and newly developed analytical methods.
Prior to Avatar, David worked at Charles River Laboratories as a Quality assurance auditor and assisted in GLP training of its QA/Facility staff. He also developed test methods for FDA submissions of novel drug compounds, prepared test methods and SOPs for QA approval, and trained employees in 21 CFR Part 11 compliant software.
David holds a BS degree in Biology from Atlantic Union College in Lancaster, Massachusetts.