Associate Director, Quality Business Enablement

Role: Associate Director, Quality Business Enablement within R&D Quality at Johnson & Johnson, focused on partnering with process owners and business leaders to develop and implement digital quality solutions that enhance operational effectiveness, inspection readiness, and GxP compliance. Responsibilities include shaping the quality solutions portfolio, leading governance and delivery of initiatives, and translating business needs into scalable, validated digital solutions. The role emphasizes inspection intelligence, audit analytics, automation, and AI to support proactive quality management. It requires influencing senior stakeholders, managing complex initiatives, and ensuring solutions meet compliance standards such as GxP, 21 CFR Part 11, and GAMP 5. Collaboration with enterprise AI, data, and tech teams ensures reuse of platforms and standards. The position involves overseeing vendor and internal resources, driving change management, and building sustainable capabilities. Qualifications include 10+ years in regulated pharma/biotech industries, 5+ years leading strategic digital initiatives, and deep GxP knowledge. Preferred skills include expertise in inspection and audit intelligence, agile delivery, and cross-functional collaboration. Educational background requires a Bachelor’s minimum, with a Master’s or PhD preferred in data science, AI, or life sciences. The role may require up to 10% travel and is based across multiple US locations. High-value biopharma specifics: regulated environment, GxP compliance, digital enablement, inspection readiness, and AI-enabled solutions.