Kathy is an experienced Quality consultant with demonstrated working history with the pharmaceutical and biotech industry. Skilled in Quality Assurance, Quality systems, Compliance, GMP manufacturing, compounding pharmacy, medical device, and continuous improvement.
Kathy has over thirty five years of global technical and managerial experience in Pharmaceutical Production and Quality Assurance with a broad range of pharmaceutical products/dosage forms such as: solid dose; sterile products (lyophilized, terminally sterilized, and aseptically filled); APIs; medical devices; biological products; vaccines; and radiopharmaceuticals.
>She has a Bachelor of Science, Pharmacy from Philadelphia College of Pharmacy & Science, Philadelphia, PA and a Master of Science, Pharmaceutical Quality Control from Temple University, Philadelphia, PA. She is an ISO 13485 certified auditor, licensed Pharmacist, and completed the Nuclear Pharmacy certification program.
Kathy has provides Quality Oversight to international contract manufacturers and suppliers throughout product lifecycle. She has extensive international experience (EU, Middle East, and Asia Pacific ) which also included support of medical devices in Japan.
Examples of projects completed:
Performed Quality System remediation activities including Quality System redesign of Document Control, Change Control, Investigation, and Complaint systems. Led cross functional work teams for redesign and system implementation.
Provided quality oversight of contract manufactures, Alliance partners and subsidiaries from initiation of commercial manufacturing to termination of relationship.
Transferred technical product and Quality System knowledge to a business partner as part of termination activities of the business relationship. This included over 70 countries and 100 SKUs.
Acted as a liaison during regulatory inspections (i.e., general inspections, pre-approval inspections, and site inspections). Coordinated written responses to any comments/observation. Coordinated product recalls and provided FDA with periodic status reports.
Provided Quality oversight for Pharmacy dispensing/ compounding operations of PET diagnostic agent and compliance to regulatory requirement and industry standards e.g. USP <797>.
Acted as Japan Quality Lead for Medical device and Alliance relationship. Managed project lifecycle from initiation to termination.
Supported Quality activities for outsourcing products by participating in external OUS audits of CMs, device and critical manufacturing material suppliers.
Performed batch review and lot disposition to assure records from Production and Quality complied with specifications and applicable regulations as a requirement for release to market.