Paula Horowitz

Background

About Paula Horowitz

Quality Assurance / Project / Data Management professional with more than 25 years cross-functional experience in Biopharmaceutical, CRO, and academic environments. Proven project manager and team builder with hands-on approach. Provides QA risk-based guidance and support for computerized systems utilized in global GCP-regulated areas in compliance with the Regulatory, Corporate, and functional areas’, standards, and policies. Exceptional track record leading and collaborating with teams for strategic design and implementation of process improvements and initiatives, including the development of standards including authoring and peer-review of SOPs, Working Practices, guidance, and training documents, many of which are relevant for risk-based data integrity approaches. Graduate of Rutger's Mini-MBA Global Entrepreneurship program Specialties: • Quality Assurance • Partner with and support clinical teams to assess and implement deliver digital health technologies into clinical trials • Exceptional Customer Service • Strategic planning • Supervision, Mentoring and Training • Effective timeline management and financial accountability • Innovative and Creative Solutions and proactive process improvements • SOP/Procedural Documentation/Change Management expertise • Technology Development, implementation and utilization for CDMS and CTMS