Judy Carmody

About Judy Carmody

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 j•••@carmodyqs.com (77••••••68

Experience

1. Member Board of Directors

   Association For Gxp Excellence

   Jan 2023 — Present

Education

• Clark University

  Ph.D., Analytical Chemistry

  1988 — 1994

• Clark University

  M.S., Analytical Chemistry

  1988 — 1993

• Worcester State University

  B.S., Chemistry

  1984 — 1988