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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.

#J-18808-Ljbffr Jobleads-US
Vacancy posted 1 day ago
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