Director, Enterprise Regulatory Compliance
Johnson & Johnson
September 03, 2026
Remote friendly (Titusville, NJ)
United States
Corporate Functions
Director, Enterprise Regulatory Compliance (Enterprise Regulatory Compliance Assessment)
Key Responsibilities:
- Serve as 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; ensure consistent application of global regulations and company standards across segments and sites.
- Review and classify Health Authority inspections and corporate cGMP audits for consistency.
- Initiate and manage issues 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 applicable requirements.
- Analyze regulatory compliance data to identify actionable insights and lead periodic data-driven compliance reviews for senior executives.
- Build AI literacy and use approved AI tools (analysis, synthesis, documentation, quality checks) in line with data governance, privacy, and responsible AI expectations.
- Lead enterprise interpretation/oversight/governance for significant compliance escalations; align actions and communications to senior leadership.
- Participate in audits, due diligence, and acquisition compliance assessments; develop strategic plans and influence outcomes in a matrixed organization.
- Provide consultative expertise on compliance issue management, including support for Health Authority responses and field action decisions.
- Provide cGMP training to corporate and internal audit teams on risk-based auditing strategies.
Qualifications:
- Bachelor’s degree minimum.
- Advanced degree or certification preferred.
- 10+ years relevant quality and compliance experience required.
- cGMP regulatory compliance experience in medical device and/or pharmaceutical regulations required.
- Health Authority or Notified Body experience preferred (not required).
- Strong written/oral communication; proven leadership in cGMP compliance.
- Ability to build cross-cultural, cross-functional relationships without line authority; influence all levels.
- Self-direction in complex matrix environment.
- Up to 20% domestic/international travel.
Preferred Skills:
Advanced analytics; audit & compliance trends; audit findings/recommendations; compliance management/risk; confidentiality; controls compliance; developing others; internal auditing; investigation techniques; legal services/function; mentorship; policy development; report writing; tactical planning; technical credibility.
Key Responsibilities:
- Serve as 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; ensure consistent application of global regulations and company standards across segments and sites.
- Review and classify Health Authority inspections and corporate cGMP audits for consistency.
- Initiate and manage issues 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 applicable requirements.
- Analyze regulatory compliance data to identify actionable insights and lead periodic data-driven compliance reviews for senior executives.
- Build AI literacy and use approved AI tools (analysis, synthesis, documentation, quality checks) in line with data governance, privacy, and responsible AI expectations.
- Lead enterprise interpretation/oversight/governance for significant compliance escalations; align actions and communications to senior leadership.
- Participate in audits, due diligence, and acquisition compliance assessments; develop strategic plans and influence outcomes in a matrixed organization.
- Provide consultative expertise on compliance issue management, including support for Health Authority responses and field action decisions.
- Provide cGMP training to corporate and internal audit teams on risk-based auditing strategies.
Qualifications:
- Bachelor’s degree minimum.
- Advanced degree or certification preferred.
- 10+ years relevant quality and compliance experience required.
- cGMP regulatory compliance experience in medical device and/or pharmaceutical regulations required.
- Health Authority or Notified Body experience preferred (not required).
- Strong written/oral communication; proven leadership in cGMP compliance.
- Ability to build cross-cultural, cross-functional relationships without line authority; influence all levels.
- Self-direction in complex matrix environment.
- Up to 20% domestic/international travel.
Preferred Skills:
Advanced analytics; audit & compliance trends; audit findings/recommendations; compliance management/risk; confidentiality; controls compliance; developing others; internal auditing; investigation techniques; legal services/function; mentorship; policy development; report writing; tactical planning; technical credibility.