Director, Regulatory Intelligence Enforcement

Johnson & Johnson

Director of Regulatory Intelligence Enforcement responsible for translating global health authority signals into actionable compliance strategies. Leading investigations and insights to strengthen GMP compliance across Johnson & Johnson.

Posted 7/16/2026full-timeNew Brunswick • District of Columbia, New Jersey, Pennsylvania • 🇺🇸 United StatesLead💰 $150,000 - $258,750 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in GMP Compliance, Regulatory Intelligence, and Inspection Management, with a strong ability to synthesize data into actionable insights and develop training materials for diverse audiences. Proficient in producing executive-level reports and dashboards while maintaining a proactive approach to continuous improvement.

Highest-signal resume keywords

GMP ComplianceRegulatory IntelligenceInspection ManagementData AnalysisTraining Development

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Data ScienceQualitative Data SynthesisQuantitative Data AnalysisExecutive ReportingDashboard CreationPredictive InsightsMachine LearningTrend DetectionInspection Readiness ProgramsCompliance Analysis

Soft Skills

Clear CommunicationInfluence in Matrixed EnvironmentProactive MindsetContinuous ImprovementHigh Integrity

Industry Keywords

Global Health Authority InspectionsEnforcement PracticesQuality AssuranceAuditPharmaceuticalMedical Device

About the role

Key responsibilities & impact

Proactively monitor, synthesize, and prioritize global enforcement signals and inspection outcomes (e.g., inspection observations, recalls, and warning letters) to produce predictive insights and identify emerging inspectorate focus areas.
Develop actionable insights for site inspection readiness programs, including themes, readiness expectations, recommended mitigations, and monitoring of progress aligned to observed enforcement trends.
Translate enforcement trends into capability-building deliverables (e.g., targeted deep-dives, inspection readiness playbooks, and training) for sector/site readiness teams and site/corporate auditors.
Support the design and maintenance of an early-warning system that combines manual curation and automated analytics (machine learning, trend detection) to surface emerging inspectorate priorities.
Partner with internal audit leaders to inform risk-based audit planning and refine audit focus areas based on external enforcement signals and evolving inspectorate priorities.
Provide enterprise regulatory insights and analysis in collaboration with Enterprise Compliance, offering a comprehensive, strategic view of global compliance posture, key risks, and priority actions across the enterprise.
Produce periodic enforcement trend reports, dashboards/briefings, and executive-ready communications for senior leaders and regulatory intelligence stakeholders.

Requirements

What you’ll need

Bachelor’s degree required; advanced degree (e.g., Engineering, Data Science, Operations Research, MBA with Data Science or Analytics Concentration) preferred.
8+ years of experience in GMP compliance, inspection management, regulatory intelligence, quality assurance, and/or audit in a global pharmaceutical and/or medical device environment.
Deep expertise in global health authority inspections and enforcement practices; strong understanding of inspectorate approaches and evolving compliance expectations.
Strong analytical capability to synthesize qualitative and quantitative data into clear descriptive analytics, leading indicators, and actionable recommendations; experience producing executive-level reports, dashboards, and briefings.
Demonstrated ability to develop and deliver inspection readiness training/materials for multiple audiences; clear, concise communication; effective influence in a matrixed environment; high integrity; and a proactive continuous-improvement mindset.
Former health authority inspector or compliance experience is preferred.

Benefits

Comp & perks

Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
10 days Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year