Associate Director, Quality Business Enablement

Scorpion Therapeutics; San Diego (CA); On-site; USD 180,000 - 230,000; Full time

Job summary

Johnson & Johnson is seeking an Associate Director, Quality Business Enablement within R&D Quality to lead the development and deployment of digital solutions that improve operational effectiveness, inspection readiness, and GxP compliance.

You will partner with process owners, govern the delivery of quality software, and drive adoption across global teams, leveraging AI, automation, and analytics to advance quality management. Up to 10% travel.

Qualifications

• Bachelor's degree required; advanced degree preferred in data science or life sciences.
• 10+ years in regulated pharma/biotech industries; 5+ years in strategic digital initiatives.
• Deep expertise in inspection and audit analytics in regulated environments.
• Experience with agile practices and vendor/offshore team management.

Responsibilities

• Partner with process owners to identify improvement opportunities.
• Lead delivery, governance, and adoption of quality solutions.
• Influence prioritization based on efficiency, risk, and compliance.
• Champion inspection intelligence, automation, and AI in quality management.
• Ensure solutions meet GxP, GAMP 5, 21 CFR Part 11 and data integrity standards.
• Collaborate with enterprise platforms and vendors; drive change management and stakeholder engagement.
• Oversee resource and vendor management.

Skills

GxP compliance

Data science

Digital enablement

Inspection analytics

Audit analytics

Program governance

Vendor management

Agile

Stakeholder influence

Travel willingness

Education

Bachelor's degree

MS/PhD in data science, AI, life sciences

Job description

Role

Associate Director, Quality Business Enablement within R&D Quality at Johnson & Johnson, focusing on developing and implementing digital solutions to enhance operational effectiveness, inspection readiness, and GxP compliance.

Responsibilities

partner with process owners and stakeholders to identify improvement opportunities; lead the delivery, governance, and adoption of quality solutions; influence prioritization based on operational efficiency, risk mitigation, and compliance; champion inspection intelligence, automation, and AI to advance quality management; ensure solutions meet GxP, GAMP 5, 21 CFR Part 11, and data integrity standards; collaborate with enterprise digital platforms and vendors; drive change management and stakeholder engagement; oversee resource and vendor management.

Qualifications

Bachelor’s degree required; MS/PhD in data science, AI, life sciences preferred. Minimum 10+ years in regulated pharma/biotech industries, with 5+ years leading strategic initiatives, digital enablement, and GxP-related solutions. Deep expertise in inspection and audit analytics, process improvement, and modern digital platforms in regulated environments. Experience in agile practices, program governance, and managing vendor or offshore teams. High-level influencing skills with senior leadership; up to 10% travel anticipated. High-value biopharma specifics include regulated GxP/GCP environments, digital solution deployment, and compliance in pharma/biotech R&D settings.