GSK · 1 day ago
Director, Human Factors, Usability and Risk
Collegeville, PA
Full-time
Hybrid
Director/Executive
$192K/yr - $320K/yrGSK is a global biopharma company with a mission to positively impact the health of 2.5 billion people by the end of the decade. They are seeking a Director of Human Factors, Usability and Risk to lead the integration of human factors engineering and risk management across their medicine and vaccine development portfolio, ensuring user-centric product designs and compliance with regulatory standards.
BiotechnologyHealth CarePharmaceutical
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
Qualification
Required
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
Preferred
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
Benefits
Health care and other insurance benefits (for employee and family)
Retirement benefits
Paid holidays
Vacation
Paid caregiver/parental and medical leave
Company
GSK
We are uniting science, technology and talent to get ahead of disease together. Our community guidelines: https://gsk.to/socialmedia
Founded in 1929
10001+ employees
H1B Sponsorship
GSK has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (56)
2023 (54)
2022 (53)
2021 (54)
2020 (72)
Funding
Current Stage
Public CompanyTotal Funding
$25.51MKey Investors
CARB-X
2021-03-02Grant· $18M
2020-09-23Grant· $7.51M
1978-01-13IPO
Leadership Team
Julie Brown
CFO
Mike Elmore
SVP & Chief Information Security Officer, GSK
Recent News
2026-02-03
2026-01-16
Company data provided by crunchbase