Director, Regulatory Intelligence Enforcement

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Legal & Compliance Job Sub Function: Enterprise Compliance Job Category: Professional All Job Posting Locations: Horsham, Pennsylvania, United States of America, New Brunswick, New Jersey, United States of America, Raritan, New Jersey, United States of America, Washington, District of Columbia, United States of America Job Description: We are searching for the best talent for Director, Regulatory Intelligence Enforcement to join our Enterprise Regulatory Compliance organization located in New Brunswick, NJ; Raritan, NJ; Horsham, PA; or Washington, DC. The Director, Regulatory Intelligence Enforcement is responsible for identifying and translating global health authority enforcement signals into actionable intelligence that strengthens inspection readiness and supports sustained GMP compliance improvement across the enterprise. The role monitors inspection outcomes, enforcement actions, and emerging inspectorate focus areas to provide forward-looking analysis that informs site readiness programs, internal audit planning, and executive decision-making. This leader produces periodic enforcement trend reports and develops a strategic, enterprise-wide view of the company’s compliance posture through an Enterprise Compliance Review, enabling proactive risk mitigation and targeted capability building. This position will report to the Head of Enterprise Regulatory Intelligence. Key Responsibilities 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. Qualifications 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. If you are under 18 years of age, you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers .Internal employees contact AskGS to be directed to your accommodation resource. #LI-Hybrid Required Skills: Preferred Skills: Advanced Analytics, Audit and Compliance Trends, Audit Findings and Recommendations, Compliance Management, Compliance Risk, Confidentiality, Controls Compliance, Developing Others, Internal Auditing, Investigation Techniques, Legal Function, Legal Services, Mentorship, Policy Development, Report Writing, Tactical Planning, Technical Credibility The anticipated base pay range for this position is : $150,000.00 - $258,750.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: 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 period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits