Director, Enterprise Regulatory Compliance
Johnson & Johnson
September 03, 2026
Remote friendly (Horsham, PA)
United States
Corporate Functions
Director, Enterprise Regulatory Compliance (Quality & Compliance)
Responsibilities
- Serve as 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; support consistent application of global regulations, company standards, and policies across segments and sites.
- Independently review and classify Health Authority inspections and corporate cGMP audits.
- Independently review and initiate issue management for health authority inspections and recalls following escalation policies and standards.
- Support inspection readiness for Health Authority and Notified Body audits and pre-approvals.
- Review US FDA response reviews (as assigned) for completeness, quality, and alignment with requirements.
- Analyze regulatory compliance data; lead periodic data-driven compliance reviews for senior leadership.
- Build AI literacy and apply approved AI-enabled tools for analysis, synthesis, documentation, and quality checks (aligned with governance, privacy, and responsible AI expectations).
- Lead enterprise interpretation/oversight/governance for compliance escalations, including alignment on actions and communications to senior leadership.
- Participate in audits, due diligence, and acquisition compliance assessments; develop strategic plans aligned to enterprise objectives.
- Provide consultative expertise on compliance issue management, including health authority responses and field action decisions.
- Provide cGMP training on risk-based auditing strategies.
Qualifications
- Bachelor’s degree minimum.
- Advanced degree or certification preferred.
- 10+ years relevant quality and compliance experience.
- cGMP regulatory compliance experience in medical device and/or pharmaceutical regulations required.
- Work experience with a Health Authority or Notified Body preferred.
- Strong communication skills; leadership track record; ability to influence across cultures/functions without line authority; ability to thrive in a matrix environment; up to 20% travel.
Preferred Skills
Advanced analytics; audit/compliance trends; investigation techniques; compliance management/risk; internal auditing; policy development; report writing; mentoring/developing others; controls compliance; confidentiality; tactical planning; technical credibility; legal function/legal services.
Benefits (time off, subject to plan/policy/date of hire)
- Vacation: 120 hours/year; Sick time: 40 hours/year (Colorado: 48; Washington: 56)
- Holiday pay (floating): 13 days/year
- Work, Personal and Family Time: up to 40 hours/year
- Parental Leave: 480 hours within one year; Bereavement: 240 immediate / 40 extended per year
- Caregiver Leave: 80 hours in a 52-week rolling period; Volunteer Leave: 32 hours/year; Military Spouse Time-Off: 80 hours/year
Responsibilities
- Serve as 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; support consistent application of global regulations, company standards, and policies across segments and sites.
- Independently review and classify Health Authority inspections and corporate cGMP audits.
- Independently review and initiate issue management for health authority inspections and recalls following escalation policies and standards.
- Support inspection readiness for Health Authority and Notified Body audits and pre-approvals.
- Review US FDA response reviews (as assigned) for completeness, quality, and alignment with requirements.
- Analyze regulatory compliance data; lead periodic data-driven compliance reviews for senior leadership.
- Build AI literacy and apply approved AI-enabled tools for analysis, synthesis, documentation, and quality checks (aligned with governance, privacy, and responsible AI expectations).
- Lead enterprise interpretation/oversight/governance for compliance escalations, including alignment on actions and communications to senior leadership.
- Participate in audits, due diligence, and acquisition compliance assessments; develop strategic plans aligned to enterprise objectives.
- Provide consultative expertise on compliance issue management, including health authority responses and field action decisions.
- Provide cGMP training on risk-based auditing strategies.
Qualifications
- Bachelor’s degree minimum.
- Advanced degree or certification preferred.
- 10+ years relevant quality and compliance experience.
- cGMP regulatory compliance experience in medical device and/or pharmaceutical regulations required.
- Work experience with a Health Authority or Notified Body preferred.
- Strong communication skills; leadership track record; ability to influence across cultures/functions without line authority; ability to thrive in a matrix environment; up to 20% travel.
Preferred Skills
Advanced analytics; audit/compliance trends; investigation techniques; compliance management/risk; internal auditing; policy development; report writing; mentoring/developing others; controls compliance; confidentiality; tactical planning; technical credibility; legal function/legal services.
Benefits (time off, subject to plan/policy/date of hire)
- Vacation: 120 hours/year; Sick time: 40 hours/year (Colorado: 48; Washington: 56)
- Holiday pay (floating): 13 days/year
- Work, Personal and Family Time: up to 40 hours/year
- Parental Leave: 480 hours within one year; Bereavement: 240 immediate / 40 extended per year
- Caregiver Leave: 80 hours in a 52-week rolling period; Volunteer Leave: 32 hours/year; Military Spouse Time-Off: 80 hours/year