Judy Carmody, Ph.D. Email and Phone Number
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Executive proficient in building operational and quality teams and systems, leading operational enhancements and quality improvements, and developing and motivating personnel to meet individual, team, and corporate objectives. A talented leader with specific expertise driving vision in CMC, nonclinical, and clinical operations, quality systems, control, and assurance, validation, qualification, strategic sourcing, vendor management, and systems development securing competitive advantage within global organizations. Accomplished in exceeding business goals within established timeframes. Proven strengths include:◆ Business Leader with an Entrepreneurial Approach - Founded and successfully grew a GMP Contract Research Organization (CRO), and registered manufacturer, to 25 plus employees and over 75 clients including small virtual to global Fortune 500 companies. Founded and successfully grew a consultancy supporting organizations in the areas of operations, quality, and IT.◆ Strategic and Tactical - Effectively led corporate quality turn-arounds through positive and influential relationship-building with stakeholders, and flexible management of vision, strategy, execution, and measurement. Developed and implemented strategic quality and operational plans at several companies ensuring GxP compliance with internal and external requirements.◆ Innovation - Demonstrated ability to increase profits and ensure GxP compliance by quickly identifying and reducing inefficiencies and thoughtfully analyzing and focusing outcomes of key performance indicators and metrics into profitable solutions.◆ Effective leadership and demonstrated teamwork – Working closely with internal Regulatory Affairs, CMC and Analytical Development departments and external Manufacturing, QA/QC, Validation, and Engineering teams, led Quality turn-around of primary CMO ensuring commercial PAI readiness. Established and maintained internal and global cross-functional, customer and vendor relationships to grow CRO sales to over $2M in 4 years. ◆ Talent – Built and led several high-performing teams and led the selection, startup and oversight of multiple CMOs and CROs worldwide; responsible for multiple internal manufacturing and analytical operations.I bring determination to get the job done and a detail-oriented, critical thinking passion that motivates and influences teams to meet and exceed timelines. I welcome an opportunity to discuss how I can assist you in securing your objectives. ☛ CONTACT INFORMATION✉ judy@carmodyqs.com✆ (774) 573-3268✰ ✰ ✰ ✰ ✰ ✰ ✰ ✰ ✰ ✰
Association For Gxp Excellence
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Founder/Principal ConsultantCarmody Quality Solutions, Llc. Aug 2015 - PresentLeveraging exceptional professional and field expertise in operations and quality, I provide thought leadership and guidance to senior and executive management and develop and build strategic relationships at all levels of management to achieve corporate goals. Selected Accomplishments: ◆ Created the Voluntary Quality Assurance VQA)® approach for building a VQA® culture, and working closely with my clients, successfully implement the approach to realize more compliant functional teams and higher quality, safer products.◆ Recognized as a Distinguished Speaker for 2018-2023 by the Society of Quality Assurance for achieving a top rating as an expert on a wide variety of Quality Assurance topics and demonstrating skill in presenting to audiences in a meaningful and engaging way.◆ Create and present courses at conferences and client facilities on topics including: » 21 CFR Part 11: Electronic Records and Electronic Signatures» Data Integrity» Stability» Investigations and CAPAs» Analytical Method Validation» Good Manufacturing Practices (cGMPs)» Risk Assessments» Training» ICH E6(R2) Compliance: Employing GMP Techniques in GCP for More Robust, Compliant Clinical TrialsOffering expertise in:◆ Acquisition or Investment Due Diligence ◆ Operational Strategic Planning ◆ Building Operation and Quality Teams ◆ Building Corporate Quality Cultures ◆ Building Quality, Clinical, CMC, Materials Management/Supply Chain, IT and Laboratory Systems ◆ Vendor Selection and Management ◆ Inspection Readiness ◆ GMP/GLP/GCP compliance ◆ Auditing ◆ Gap Analyses ◆ Event Investigations/CAPAs ◆ Validation (including process, computerized systems, analytical methods, cleaning, manufacturing equipment) ◆ Equipment calibration/maintenance programs ◆ Method validation/method transfer ◆ Training and developing training programs ◆ Materials managementPlease visit the website and click on "Videos" to learn more about my scientific approach to Quality and Quality Systems.
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Member Board Of DirectorsAssociation For Gxp Excellence Jan 2023 - PresentLower Salford, Pennsylvania, Us
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Scientific Advisory Board MemberDan Lewis Foundation Apr 2022 - Present
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Biotechnology Advisory Board MemberClark University Jul 2022 - PresentWorcester, Massachusetts, Us -
MemberBoston Harbor Angels Mar 2022 - Mar 2023Boston, Ma, Us -
Svp, OperationsTranscode Therapeutics, Inc. (Nasdaq: Rnaz) Aug 2021 - Dec 2021Newton, Massachusetts, UsManaged company operations with responsibility for CMC, Nonclinical, Clinical, IT, Regulatory and Quality. Selected Accomplishments: ◆ Developed and implemented strategic plans across organization; led execution teams. Initiated and contributed to the design of HR and Procurement Policies.◆ Coordinated with leadership to develop and implement organizational strategies and promote progress towards business objectives.◆ Led selection, startup, and management of manufacturing, testing, Nonclinical, IT and logistic vendors world-wide. Contributed to the evaluation of Regulatory and Clinical vendors.◆ Provided personnel training to accomplish short- and long-term goals for growth and product development. -
Vp, Operations (Consultant)Transcode Therapeutics, Inc. (Nasdaq: Rnaz) Aug 2019 - Aug 2021Newton, Massachusetts, UsEstablished operational efficiencies through development of organizational systems for controlled document management, training, data integrity, vendor selection and management, vendor audits, complaints, batch disposition, specifications, risk assessments, deviations, investigations, CAPAs and material review boards.Selected Accomplishments: ◆ Secured and equipped laboratory for process development and research efforts.
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Vice President, Quality Assurance & Quality Control, Sr. Dir., Quality Assurance & Quality ControlMost Recent 2011 - 2015Held progressive roles of responsibility from Senior Director, Quality Assurance & Quality Control to Vice President, Quality Assurance & Quality Control at companies including: Ziopharm Oncology, Inc., Synageva Biopharma Corp. (currently Alexion Pharmaceuticals, Inc.), and Flexion Therapeutics, Inc. Established the corporate Quality culture and systems, and provided Quality oversight of internal and external operations.Selected Accomplishments: ◆ Led Quality turn-around of primary CMO ensuring successful commercial PAI.◆ Built and implemented GMP/GLP vendor and internal audit programs achieving >30% reduction in non-compliances.◆ Initiated Corporate Quality Goals successfully improving training compliance to 98% in 8 months.Core areas of expertise include: Validation, GMP, Quality Assurance, Chromatography, Quality System, SOP, Biotechnology, FDA, Management, Vendor Management, Process Improvement, GLP, Pharmaceutical Industry, Analytical Method, Operations Management, Team Building, CRO, CAPA, 21 CFR Part 11, Formulation, Training., Quality Control, Life Sciences, Analytical Chemistry, Technology Transfer, Drug Discovery, IND, Pharmaceutics, Biopharmaceuticals, V&V, HPLC, Computer System, Quality Systems Design, Problem Solving, Motivating teams, CAPA system management, Quality Auditing,, Medical Devices, Regulatory Affairs, Drug Development, Clinical Development, Regulatory Submissions, GCP, Protein Chemistry, Clinical Trials, GxP, CMC☛ CONTACT INFORMATION✉ judy@carmodyqs.com✆ (774) 573-3268✰ ✰ ✰ ✰ ✰ ✰ ✰ ✰ ✰ ✰
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Director, Cmc & QbdVertex Pharmaceuticals 2010 - 2011Boston, Ma, UsEstablished and maintained the Commercial QC laboratory and associated Quality Systems.Selected Accomplishments: ◆ Led development, in four month time frame, of commercial quality control laboratory playing a critical role in the successful launch of Incivek®.◆ Re-engineered the commercial reference standard program achieving better traceability and efficiency saving the company >$100K in rush fees, redundant testing and missed testing.◆ Restructured vendor oversight program resulting in 25% reduction in turnaround times, improved quality and >$250K in cost savings. -
President/FounderAvatar Pharmaceutical Services, Inc. 2002 - 2010Founded and grew a FDA registered contract research/manufacturing organization.Selected Accomplishments: ◆ Established and continually enhanced company’s Quality Systems resulting in no critical or major findings while simultaneously expanding the service offering to include downstream purification/manufacturing of a protein intermediate. ◆ Developed and implemented instrumentation management program to include qualification and maintenance reducing service plan costs by 75% and instrumentation downtime by 50%.◆ Co-authored Chapter 7: Purity and Content Analysis of Oligonucleotides by Capillary Gel Electrophoresis in Handbook of Analysis of Oligonucleotides and Related Products establishing our expertise in the field of oligonucleotide analysis resulting in increased revenue.
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Ymc Brand ManagerWaters Corporation 1999 - 2002Milford, Ma, UsGrew incremental sales in the Americas for YMC brand HPLC column products and associated HPLC accessories.Selected Accomplishments: ◆ Developed marketing concepts to break into new markets yielding a 4% increase in annual sales. -
Senior Applications ChemistWaters Corporation 1997 - 1999Milford, Ma, UsDeveloped analytical HPLC and SPE applications in support of global marketing initiatives Selected Accomplishments:◆ Developed applications; contributing author to Chapter 3: Design of Rapid Gradient Methods for the Analysis of Combinatorial Chemistry Libraries and the Preparation of Pure Compounds in Advances in Chromatography helping to launch our high-throughput line of products.
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Senior Analytical Research Chemist, Analytical/Quality Control Lab. Manager, Validation ManagerPrior To 1997 1993 - 1997Held progressive roles of responsibility from Senior Analytical Research Chemist, Analytical/Quality Control Laboratory Manager and Validation Manager at pharmaceutical companies including: Copley Pharmaceuticals, Inc., Pharm-Eco Laboratories (currently Johnson- Matthey) and Zeneca Pharmaceuticals, Inc. (currently AstraZeneca).
Judy Carmody, Ph.D. Skills
Judy Carmody, Ph.D. Education Details
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Clark UniversityAnalytical Chemistry -
Clark UniversityAnalytical Chemistry
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Worcester State UniversityChemistry
Frequently Asked Questions about Judy Carmody, Ph.D.
What company does Judy Carmody, Ph.D. work for?
Judy Carmody, Ph.D. works for Association For Gxp Excellence
What is Judy Carmody, Ph.D.'s role at the current company?
Judy Carmody, Ph.D.'s current role is Entrepreneur | Operations & Quality Leader | Life Science Executive | Navigator of the Ambiguous | Strategist | Tactician.
What is Judy Carmody, Ph.D.'s email address?
Judy Carmody, Ph.D.'s email address is ju****@****arm.com
What schools did Judy Carmody, Ph.D. attend?
Judy Carmody, Ph.D. attended Clark University, Clark University, Worcester State University.
What skills is Judy Carmody, Ph.D. known for?
Judy Carmody, Ph.D. has skills like Chromatography, Team Building, Combinatorial Chemistry, Specifications, Suppliers, Method Transfer, Chemistry, Vendors, Sales, Motivating Team Members And Staff, Gxp, Biotechnology.
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