Kate Smith, QP

QP consultant

Kate is a Qualified Person with 20 years’ experience within the medical device and pharmaceutical industry, including human and veterinary medicines for marketed and clinical use with a wide range of dosage forms. Kate has been a member of CatSci’s Scientific Advisory Board since 2020 and has recently been advising and QP-supporting the launch of the CatSci Dagenham Analytical Services Laboratory into the GMP environment.

Kate graduated from the University of Glamorgan with a BSc (Hons) in Forensic Science before moving on to complete an MSc in Pharmaceutical Quality and GMP from the University of Strathclyde. Kate’s extensive industry experience began with British Biocell Ltd, gaining expertise in diagnostic medical devices before moving to Norgine Ltd, where she gained experience in pharmaceutical manufacturing. Kate then joined previously Penn Pharmaceutical Services Ltd within the QA department, where she led multiple Lean initiatives before being promoted and gaining her QP qualification. Kate has built an extensive knowledge of the specialist area of highly potent products, having been part of the design and implementation team delivering the award-winning Contained Manufacturing Facility at the PCI Tredegar site. Kate has supported PCI with multiple roles, including the Director of Manufacturing and Director of Strategic Operations, with the principal role of developing the five-year strategic plan for the PCI Tredegar site as part of the global PCI organization. Kate’s current role as Director Quality is a move into the Global Quality Leadership Team with the primary function of maintaining regulatory compliance for medical products to a global supply chain and providing the strategic direction for the Quality department. As a member of the ISPE Central Committee, Kate is also involved in the promotion of pharmaceutical knowledge within industry to deliver manufacturing and supply chain innovation, operational excellence, and regulatory insights to enhance industry efforts to develop, manufacture and reliably deliver quality medicines to patients.

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