Associate Director, Quality Business Enablement

Role: Associate Director, Quality Business Enablement within R&D Quality at Johnson & Johnson, focusing on partnering with process owners and business leaders to develop and govern digital and operational quality solutions that enhance compliance, inspection readiness, and operational efficiency. Responsibilities include shaping solution portfolios aligned with strategic objectives, leading delivery governance, influencing prioritization based on business value, and championing inspection intelligence and AI capabilities. The role ensures solutions comply with GxP/GCP regulations, data integrity, and validation standards, and integrates enterprise technology platforms. It involves stakeholder engagement, change management, vendor oversight, and driving adoption of scalable, validated solutions. Qualifications: Bachelor’s degree (MS/PhD preferred), 10+ years in regulated industries, with 5+ years leading strategic initiatives, especially in digital enablement, inspection intelligence, and GxP compliance. Deep expertise in GxP/GCP, GAMP 5, CSA/CSV, data integrity, audit trail, and CFR 21 Part 11; experience with agile delivery, process improvement, and vendor management. High-value specifics include experience in pharmaceutical or biotech sectors, regulated environments, and digital health solutions, with up to 10% travel. The position is based in NJ, PA, or CA, with a focus on innovation in quality systems, digital transformations, and continuous improvement within a life sciences context.