Associate Director, Quality Business Enablement
Scorpion Therapeutics
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Job summary
Johnson & Johnson’s R&D Quality is seeking an Associate Director, Quality Business Enablement to design and deliver digital quality solutions that improve efficiency, inspection readiness, and GxP compliance. You will partner with process owners, oversee solution delivery and lifecycle governance, and lead change management across enterprise digital teams with travel up to 10%.
This role requires 10+ years in pharma/biotech, 5+ years leading digital initiatives, and deep knowledge of GxP, GAMP
Qualifications
- Bachelor's degree in life sciences, data science, or related field required/preferred (MS/PhD)
- 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
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
Skills
Education
Job description
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.
- 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.
- 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.
- focus on GxP compliance, inspection readiness, AI-enabled quality solutions, regulated industry experience, and cross-functional leadership.
multiple locations in the US (NJ, PA, CA) with up to 10% domestic/international travel.
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