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Director, Regulatory Intelligence Enforcement
Johnson & JohnsonDirector, Regulatory Intelligence Enforcement at Johnson & Johnson identifying enforcement signals and providing strategic compliance insights. Ensuring inspection readiness across global operations for sustainable compliance improvement.
Core Competencies
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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.
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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
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
- Eligible for the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
- Eligible to participate in the Company’s long-term incentive program.