Director, Quality Enablement & Audit Intelligence

Jobtailor; California (MO); On-site; USD 180,000 - 240,000; Full time

Job summary

Johnson & Johnson Technology is recruiting a senior RDQ leader to align audit and quality systems with strategic objectives. You will steer cross-functional teams, assess opportunities, and deliver validated, compliant AI-enabled solutions within regulated environments.

The role requires a strong track record in influencing VP-level stakeholders, deep GxP/GCP expertise, and hands-on governance of complex portfolios across internal and external delivery teams.

Qualifications

• A minimum of a Bachelor’s or equivalent University degree is required.
• MS/PhD preferred in data science, statistics, AI, computer science/engineering, life sciences or related fields.
• 10+ years in pharmaceutical, biotechnology, or other regulated industries.
• 5+ years leading strategic initiatives, including execution, process improvement, and digital enablement.
• Inspection and audit intelligence experience.
• Proven track record influencing senior leadership and stakeholders through VP level and above.
• Deep expertise in GxP/GCP requirements, GAMP 5, CSA/CSV, data integrity, audit trail, and 21 CFR Part 11 expectations.
• Working understanding of traditional and modern digital capabilities and quality-related systems in a regulated environment.
• Demonstrated experience gathering business requirements from process owners and leading delivery of validated or compliance-sensitive solutions.
• Experience in agile delivery, product or program governance, UAT oversight, adoption planning, and value realization.
• Experience directing vendor or offshore delivery teams preferred.
• Strong collaboration, alignment, change leadership, and influencing skills across a matrixed organization.
• High degree of accuracy and attention to detail.
• Excellent interpersonal, oral, and written communication skills.

Responsibilities

• Partner with process owners, functional leaders, and stakeholders to understand audit, inspection management, and quality systems processes and identify improvement opportunities.
• Align priorities into a cohesive portfolio supporting RDQ strategic objectives, operational excellence, and compliance outcomes.
• Provide program leadership and governance for quality solution initiatives across scope, resources, risks, timelines, validation expectations, and outcome measures.
• Evaluate opportunities, trade-offs, and business value to support prioritization and investment decisions.
• Define business outcomes, success measures, and adoption expectations and ensure requirements are translated into scalable solutions.
• Champion inspection intelligence, audit analytics, automation, and AI-enabled capabilities.
• Ensure solutions comply with GxP/GCP, GAMP 5, CSA/CSV, data integrity, audit trail, 21 CFR Part 11, responsible AI, privacy, security, and governance expectations.
• Serve as RDQ liaison to Enterprise AI, JJIM Quality Data & Analytics, and Johnson & Johnson Technology.
• Drive stakeholder engagement, communication, training, organizational readiness, and adoption.
• Build sustainable business capabilities, strengthen knowledge sharing, and reduce operational dependency risk.
• Oversee internal, external, offshore, and technology delivery resources and review deliverables.
• Communicate portfolio priorities, progress, risks, decisions, realized value, and adoption status to senior leadership.
• Interpret ambiguous business problems, create proposals, and implement improvement solutions.
• Manage complex initiatives independently and maintain awareness of regulatory developments for AI-enabled decision-making in GxP processes

Skills

GxP/GCP Compliance

Audit Intelligence

Strategic Initiative Leadership

Data Science

Agile Delivery

Stakeholder Engagement

Communication

Education

Bachelor's degree

MS/PhD preferred

Tools

Audit Analytics

Quality Data & Analytics

Automation

AI-Enabled Capabilities

Digital Capabilities

Job description

Johnson & Johnson Technology is recruiting a senior RDQ leader to align audit and quality systems with strategic objectives. You will steer cross-functional teams, assess opportunities, and deliver validated, compliant AI-enabled solutions within regulated environments.

The role requires a strong track record in influencing VP-level stakeholders, deep GxP/GCP expertise, and hands-on governance of complex portfolios across internal and external delivery teams.