Judith Samardelis

About Judith Samardelis

Experienced in managing, directing and leading QA and IT QA in regulatory/pharmaceutical environment with hands on experience in research and development, clinical and commercial systems validation, including randomization of cohorts, clinical supplies, laboratory skills, PK/PD and preclinical studies.Strong working practical knowledge of GMP, GLP, GCP, Medical Devices, GPV and EU regulations. Experience with participation and site support in Board of Health Inspections, not limited to FDA, EMA, Canada, Japan, Brazil, IMB, MRH, Korea, Turkey, TGA. Multiple instances of building/rebuilding QMS documentation. Experience QA representation in the development and validation of HCP platforms and portals creating a streamlined repeatable process for the validation and incremental software releases using AGILE methodology for GxP regulated platforms. Through the creation of a Master Plan, developed the process for management of Mergers, Acquisitions, Divestitures and Collaborations of companies and associated systems, electronic records and documentation and the merger of Quality Management Systems. Experience in scaling and setting up Commercial Websites and HCP portals in alignment with FDA regulations for prescription drug advertising. SKILLS: Directing Preclinical studies at UCLA, Tufts, and Emory University, R&D and GLP Biological assay and method development and validation. Design of Experiment in response to an FDA request following an IND application, GMP laboratory skills and GLP laboratory skills, Conversion of a R&D Lab into a certified GLP laboratory,Mergers and Acquisitions, creating a Master Plan and templates supporting migration of Clinical and R&D data, Effectively managed the merger between numerous companies with alignment of processes and Quality Systems, Created a Global process for the Data Integrity assessment of IT global GxP systems, in alignment with site(s) DI processes, linking into the Periodic Review Process based upon risk and predicate rule systems containing e records, Management and validation of E Clinical Systems including the randomization of cohorts, supporting processes and clinical supplies and distribution, Experience in regulatory filings for combination products, Experience in validation activities from a QA technical regulatory perspective, including software development and testing through delivery into the production space. QA oversight in the validation of e-Clinical, GMP lab and manufacturing systems. Experience auditing Cloud service providers and implementation of cloud solutions. Co-Chair of the GAMP Cloud Sig.

Experience

1. Senior Director, Head of Computer Systems Quality Assurance, Glaxosmithkline

   GSK

   Dec 2021 — Present

Education

• The Johns Hopkins University

  Master of Science (M.S.)

• University of New Hampshire

  BA