Director, Human Factors, Usability and Risk

Key Responsibilities

• Strategic leadership and capability assessment to develop and drive a strategic vision for HFE UI and RM that supports a broad portfolio of combination products and implement continuous improvements across the full product ecosystem.
• Foster an enterprise culture that integrates human factor engineering (HFE) and risk management (RM) early and across the product development lifecycle ensuring seamless incorporation into the design control framework and regulatory submissions while ensuring lifecycle success.
• Oversee and manage 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 update of 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 / challenges to refine processes and framework.
• Set vision and communicate operational strategies opportunities and progress to senior leadership and key stakeholders / partners to drive product success and enterprise capability.

Why You

Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Bachelors 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 ofHuman 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.

Preferred Qualification
If you have the following characteristics it would be a plus:

• 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.

Location and Working Model
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.

What we value
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.

Ready to apply
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.