Enrica Papi
Associate Director, Human Factors @GSK
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WORK HISTORY
Associate Director, Human Factors @GSK
Promoted to lead Human Factors (HF) function within GSK/ViiV, managing and mentoring a team of HF Engineers. Responsible for leading all HF/usability activities for drug-device combination products, medical devices (including emerging technologies and platform devices), and standalone drug products. Key responsibilities include- Developing and executing regulatory HF strategies for protocol reviews and health authority submissions across clinical and commercial development phases (e.g, IND, BLA)- Authoring, reviewing, and approving HF documentation, including study protocols/reports, risk analyses, Design History Files, labeling documents (e.g, Instructions for Use)- Integrating HF principles early in product development through formative studies and user-centric investigations to ensure safety, usability, and alignment with user needs- Establishing HF workflows, templates, and compliance processes aligned with international regulations and leveraging post-market surveillance data to optimize usability strategies- Directing formative, summative and anthropometric studies- Collaborating cross-functionally with regulatory, quality, packaging, medical, marketing, and manufacturing teams to ensure holistic product development- Supporting internal/external audits, root cause investigations, and external vendor management to maintain quality and compliance standards.
EDUCATION
Alma Mater Studiorum – Università di Bologna
BEng degree, Biomedical Engineering
University of Strathclyde
Doctor of Philosophy (Ph.D.), Biomechanics
University of Strathclyde
Master of Science (MSc), Bioengineering and Biomedical Engineering
SKILLS
ABOUT ENRICA PAPI
Human Factors/Usability Engineer
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