Associate Director, Quality Business Enablement

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California (MO)

On-site

USD 180,000 - 240,000

Full time

6 days ago

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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

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

Requirements

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

Core Competencies

Demonstrates expertise in GxP/GCP compliance, audit intelligence, and quality systems management, with a strong focus on driving strategic initiatives and digital enablement in regulated industries. Proven ability to influence senior leadership and stakeholders while ensuring successful adoption of scalable solutions.

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