Associate Director, Quality Business Enablement
Jobleads-US
Role: Associate Director, Quality Business Enablement within R&D Quality at Johnson & Johnson, focusing on designing and delivering digital quality solutions that enhance operational efficiency, inspection readiness, and GxP compliance.
Responsibilities
- partner with process owners and stakeholders to develop a portfolio of quality systems and automation initiatives
- oversee solution delivery, validation, and lifecycle governance
- influence prioritization based on operational impact and risk
- promote inspection intelligence and AI-enabled innovations
- ensure solutions meet GxP, GAMP 5, and data integrity standards
- serve as a liaison with enterprise digital teams
- lead change management and resource oversight.
Requirements
- Bachelor's degree (MS/PhD preferred) in life sciences, data science, or related fields
- 10+ years in pharma/biotech regulated environments
- 5+ years leading strategic, digital, and process improvement projects
- deep knowledge of GxP, GAMP 5, audit intelligence, and quality systems
- experience with validated solutions, agile delivery, and vendor management
- proven stakeholder influence skills.
High-Value
- focus on GxP compliance, inspection readiness, AI-enabled quality solutions, regulated industry experience, and cross-functional leadership.
Work setup
multiple locations in the US (NJ, PA, CA) with up to 10% domestic/international travel.
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