Director, Human Factors, Usability and Risk in Ware

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success.

To lead and strategically oversee the integration of human factors engineering, user insights, and risk management across the GSK medicine and vaccine development portfolio. Provide enterprise-level direction to assess and continually improve existing capabilities, ensuring user-centric product designs, optimal alignment with the CMC Operating Model, and compliance with all applicable standards and regulatory guidelines for Medical Devices and Combination Products across the full product lifecycle. This role combines human factors with risk management across the product development lifecycle.

• Strategic leadership and capability assessment to develop and drive a strategic vision for human factors engineering (HFE), user insights (UI), and risk management (RM) that supports a broad portfolio of combination products and implements continuous improvements across the full product ecosystem.
• Foster an enterprise culture that integrates HFE and RM early and across the product development lifecycle, ensuring seamless incorporation into the design control framework and regulatory submissions while ensuring lifecycle success.
• Oversee risk-based approaches while integrating best practices to address regulatory challenges, integrate with combination product design and manufacturing risk assessments, ensure compliance with relevant standards and regulatory requirements (FDA, EMA, etc.), and minimize on-market risks.
• Embed design-enabling patient and user insights in early-stage concept development, ensuring alignment with CMC models and product design requirements.
• Direct and oversee literature data gathering, anthropometric research, and formative and summative HF studies aimed at creating design solutions to meet user needs.
• Interface effectively with cross-functional teams (Device Development, Medical, Packaging, Regulatory, CMC, Drug Product, etc.) and internal partners (e.g., Manufacturing Science and Technology (MSAT), Artwork and Packaging (APS), etc.) to ensure integrated and harmonized product development.
• Collaborate with Post-Market Surveillance (PMS) on collecting real-world data (complaints, adverse events, user feedback, etc.) and drive updates to risk assessments and implementation of corrective actions to ensure long-term product safety and effectiveness.
• Manage a skilled internal team supported by an external partnership framework to ensure effective and efficient execution; coach and mentor team members to foster proactive engagement within product development process, the CMC Operating Model and broader project teams.
• Assess and evaluate flexible, scalable models for collaboration internally and externally to support program and strategic deliverables while staying abreast of industry practices, regulatory trends, and portfolio needs and challenges to refine processes and framework.
• Set vision and communicate operational strategies, opportunities, and progress to senior leadership and key stakeholders to drive product success and enterprise capability.

• Bachelor's degree in human factors, industrial design, engineering, psychology, nursing, or related field, plus significant relevant experience. Advanced degree preferred.
• Demonstrated record of scientific achievement and a broad and integrated knowledge of Human Factors, IFU development, Combination Product requirements, Risk Management for Medical Devices, and application of User Insights and/or Patient Support needs across the product lifecycle.
• Understanding of relevant regulatory and compliance standards, including ISO standards, MDR, Design Controls, etc., and ability to review/author regulatory documents and responses.

• Advanced degree (MS, PhD) in human factors, ergonomics, industrial design, or related discipline.
• Experience leading or managing human factors teams or matrixed resources.
• Hands-on experience with medical device, combination product, or packaging usability work.
• Familiarity with quantitative and qualitative research methods, and experience with statistical analysis of usability data.
• Experience working in global, cross-cultural teams and supporting multiple geographic regulatory requirements.
• Certification or formal training in human factors, usability engineering, or risk management.

This role is based in the United States and offers a hybrid working arrangement. You will be expected to work on-site regularly for team collaboration, lab-based studies, and stakeholder meetings. Occasional travel may be required.

You will join a collaborative environment that values patient focus, transparency, respect, and integrity. We want people who communicate clearly, build strong relationships, and take responsibility for delivering high-quality outcomes. We welcome applicants who bring curiosity, empathy, and a commitment to continuous learning and inclusion.

If you are motivated to shape safe and usable solutions that improve health outcomes, we want to hear from you. Please submit your application and tell us how your experience will help advance human-centered design and risk management at GSK.