Director, Enterprise Regulatory Compliance

Johnson & Johnson

Director of Enterprise Regulatory Compliance overseeing cGMP compliance for pharmaceutical and medical devices at Johnson & Johnson. Engaging with leadership to mitigate compliance risks and enhance regulatory strategies.

Posted 7/29/2026full-timeNew Brunswick • New Jersey, Pennsylvania • 🇺🇸 United StatesLead💰 $150,000 - $258,750 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory compliance and quality assurance within the pharmaceutical and medical device sectors, with a strong focus on cGMP standards and health authority interactions. Proven ability to analyze compliance data and lead strategic initiatives while fostering effective communication and relationships across diverse teams.

Highest-signal resume keywords

CGMP Regulatory ComplianceHealth Authority InteractionRegulatory Compliance Data AnalysisLeadership in ComplianceCommunication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory ComplianceQuality AssuranceRisk ManagementData AnalysisIssue ManagementAudit ReviewPolicy InterpretationInspection ReadinessCGMP TrainingCompliance Strategy Development

Soft Skills

Relationship BuildingSelf-DirectionInfluencing SkillsAdaptabilityCollaboration

Tools & Technologies

AI Enabled ToolsData Governance Tools

Certifications & Qualifications

Advanced Degree in Applicable FieldRegulatory Compliance Certification

Industry Keywords

Pharmaceutical RegulationsMedical Device RegulationsHealth AuthorityNotified BodyCompliance Audits

About the role

Key responsibilities & impact

Serve as the Enterprise Regulatory Compliance Single Point of Contact and subject-matter leader for policy interpretation, issue triage, and decision support across pharmaceutical and medical device businesses
Provide independent assessments of manufacturing, quality, and compliance risks, supporting consistent application of global regulations, company standards, and policies across segments and sites
Independently review and classify Health Authority inspections and corporate cGMP audits to ensure consistency across businesses
Independently review and initiate issue management for health authority inspections and recalls across the pharmaceutical and medical device businesses following escalation policies and standards
Support inspection readiness activities in preparation for Health Authority and Notified Body audits and pre-approvals
Review US FDA response reviews, as assigned, to ensure completeness, quality, and alignment with applicable requirements
Analyze large volumes of regulatory compliance data to identify actionable insights and lead periodic data driven compliance reviews for senior executive leadership
Actively build and maintain AI literacy and fluency, and apply approved AI enabled tools to improve individual and team ways of working (e.g., analysis, synthesis, documentation, and quality checks), in alignment with data governance, privacy, and responsible AI expectations
Lead enterprise interpretation, oversight, and governance for significant compliance escalations, including alignment on required actions and communications to senior leadership
Participate, as needed, in corporate regulatory compliance audits, due diligence, and acquisition compliance assessments; develop strategic plans aligned with enterprise objectives and influence outcomes in a complex, matrixed organization
Provide consultative expertise on compliance issue management, including support for health authority responses and field action decisions in accordance with policy requirements
Provide cGMP training to corporate and internal audit teams on risk-based auditing strategies for key compliance issues and emerging trends

Requirements

What you’ll need

A minimum of a bachelor’s degree is required
Advanced degree in an applicable field of study or certification is preferred
A minimum of 10 years’ relevant quality and compliance experience is required
Work experience for a Health Authority or Notified Body is preferred but not required
Prior work experience in cGMP regulatory compliance in medical device and/or pharmaceutical regulations is required
Strong written and oral communication skills that can be adapted to the appropriate levels of a large complex organization to facilitate regulatory compliance risk understanding is required
Track record of successful leadership skills in cGMP compliance is required
Ability to build productive relationships to work and influence effectively across cultures and functions without line authority is required
Self-direction and ability to thrive in a complex matrixed environment is required
Up to 20% domestic and international travel may be required as business demands

Benefits

Comp & perks

Health insurance
Retirement plan (pension)
401(k)
Long-term incentive program
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