Associate Director, Quality Business Enablement

Role: Associate Director, Quality Business Enablement within R&D Quality at Johnson & Johnson, focusing on developing and implementing digital solutions to enhance operational effectiveness, inspection readiness, and GxP compliance. Responsibilities: partner with process owners and stakeholders to identify improvement opportunities; lead the delivery, governance, and adoption of quality solutions; influence prioritization based on operational efficiency, risk mitigation, and compliance; champion inspection intelligence, automation, and AI to advance quality management; ensure solutions meet GxP, GAMP 5, 21 CFR Part 11, and data integrity standards; collaborate with enterprise digital platforms and vendors; drive change management and stakeholder engagement; oversee resource and vendor management. Qualifications: Bachelor’s degree required; MS/PhD in data science, AI, life sciences preferred. Minimum 10+ years in regulated pharma/biotech industries, with 5+ years leading strategic initiatives, digital enablement, and GxP-related solutions. Deep expertise in inspection and audit analytics, process improvement, and modern digital platforms in regulated environments. Experience in agile practices, program governance, and managing vendor or offshore teams. High-level influencing skills with senior leadership; up to 10% travel anticipated. High-value biopharma specifics include regulated GxP/GCP environments, digital solution deployment, and compliance in pharma/biotech R&D settings.