Director, Enterprise Regulatory Compliance
Johnson & Johnson
September 03, 2026
Remote friendly (Washington, DC)
United States
Corporate Functions
Director, Enterprise Regulatory Compliance (Enterprise Regulatory Compliance Assessment)
Responsibilities:
- Serve as Enterprise Regulatory Compliance Single Point of Contact for policy interpretation, issue triage, and decision support across pharma and medical devices.
- Provide independent assessments of manufacturing, quality, and compliance risks to support consistent application of regulations, standards, and policies.
- Review and classify Health Authority inspections and corporate cGMP audits for consistency.
- Initiate issue management for inspections and recalls following escalation policies/standards.
- Support inspection readiness for Health Authority and Notified Body audits and pre-approvals.
- Review assigned US FDA response reviews for completeness, quality, and alignment.
- Analyze compliance data to produce actionable insights and lead data-driven compliance reviews.
- Apply approved AI-enabled tools to improve ways of working (consistent with governance/privacy/responsible AI expectations).
- Lead oversight/governance for significant compliance escalations and align required actions/communications.
- Support audits, due diligence, and acquisition compliance assessments; develop strategic plans.
- Provide consultative expertise on compliance issue management and health authority/field action decisions.
- Provide cGMP training on risk-based auditing for key issues and trends.
Qualifications:
- Bachelor’s degree minimum.
- Advanced degree/certification preferred.
- 10+ years relevant quality/compliance experience required.
- Health Authority/Notified Body experience preferred.
- cGMP regulatory compliance experience in medical device and/or pharma required.
- Strong written/oral communication; demonstrated leadership in cGMP compliance; relationship building/influence without line authority; ability to work across all levels; self-directed in a 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 Function/Services; Mentorship; Policy Development; Report Writing; Tactical Planning; Technical Credibility.
Benefits (time off):
Vacation 120 hrs/yr; Sick time 40 hrs/yr (CO 48; WA 56); Holiday pay (incl. floating) 13 days/yr; Work/Personal/Family Time up to 40 hrs/yr; Parental Leave 480 hrs/yr; Bereavement Leave 240 hrs (immediate) and 40 hrs (extended)/yr; Caregiver Leave 80 hrs in 52-week rolling period; Volunteer Leave 32 hrs/yr; Military Spouse Time-Off 80 hrs/yr.
Responsibilities:
- Serve as Enterprise Regulatory Compliance Single Point of Contact for policy interpretation, issue triage, and decision support across pharma and medical devices.
- Provide independent assessments of manufacturing, quality, and compliance risks to support consistent application of regulations, standards, and policies.
- Review and classify Health Authority inspections and corporate cGMP audits for consistency.
- Initiate issue management for inspections and recalls following escalation policies/standards.
- Support inspection readiness for Health Authority and Notified Body audits and pre-approvals.
- Review assigned US FDA response reviews for completeness, quality, and alignment.
- Analyze compliance data to produce actionable insights and lead data-driven compliance reviews.
- Apply approved AI-enabled tools to improve ways of working (consistent with governance/privacy/responsible AI expectations).
- Lead oversight/governance for significant compliance escalations and align required actions/communications.
- Support audits, due diligence, and acquisition compliance assessments; develop strategic plans.
- Provide consultative expertise on compliance issue management and health authority/field action decisions.
- Provide cGMP training on risk-based auditing for key issues and trends.
Qualifications:
- Bachelor’s degree minimum.
- Advanced degree/certification preferred.
- 10+ years relevant quality/compliance experience required.
- Health Authority/Notified Body experience preferred.
- cGMP regulatory compliance experience in medical device and/or pharma required.
- Strong written/oral communication; demonstrated leadership in cGMP compliance; relationship building/influence without line authority; ability to work across all levels; self-directed in a 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 Function/Services; Mentorship; Policy Development; Report Writing; Tactical Planning; Technical Credibility.
Benefits (time off):
Vacation 120 hrs/yr; Sick time 40 hrs/yr (CO 48; WA 56); Holiday pay (incl. floating) 13 days/yr; Work/Personal/Family Time up to 40 hrs/yr; Parental Leave 480 hrs/yr; Bereavement Leave 240 hrs (immediate) and 40 hrs (extended)/yr; Caregiver Leave 80 hrs in 52-week rolling period; Volunteer Leave 32 hrs/yr; Military Spouse Time-Off 80 hrs/yr.