Director, Enterprise Regulatory Compliance
Johnson & Johnson
September 03, 2026
Remote friendly (Athens, GA)
United States
Corporate Functions
Director, Enterprise Regulatory Compliance (Enterprise Regulatory Compliance Assessment)
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; ensure consistent application of global regulations, company standards, and policies.
- Review and classify Health Authority inspections and corporate cGMP audits; ensure consistency across businesses.
- 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.
- Analyze regulatory compliance data and lead periodic data-driven compliance reviews for senior leadership.
- Build AI literacy and apply approved AI tools in alignment with data governance, privacy, and responsible AI expectations.
- Lead oversight/governance for significant compliance escalations; align required actions and communications to senior leadership.
- Participate in regulatory compliance audits, due diligence, and acquisition compliance assessments; develop strategic plans and influence outcomes.
- 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.
Qualifications:
- Bachelor’s degree minimum.
- Advanced degree/certification preferred.
- 10+ years relevant quality and compliance experience required.
- Health Authority/Notified Body experience preferred (not required).
- Prior cGMP regulatory compliance experience in medical device and/or pharmaceutical regulations required.
- Strong written/oral communication; leadership track record; ability to influence without line authority; thrive in a complex matrix; up to 20% travel.
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/Services; Mentorship; Policy Development; Report Writing; Tactical Planning; Technical Credibility.
Benefits (time off, subject to policy/date of hire):
- Vacation: 120 hours/year; Sick: 40 hours/year (CO 48; WA 56)
- Holiday pay (incl. floating): 13 days/year
- Work/Personal/Family time: up to 40 hours/year
- Parental leave: 480 hours; Bereavement: 240 (immediate) / 40 (extended)
- Caregiver leave: 80 hours in a 52-week rolling period (listed as 10 days)
- 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; ensure consistent application of global regulations, company standards, and policies.
- Review and classify Health Authority inspections and corporate cGMP audits; ensure consistency across businesses.
- 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.
- Analyze regulatory compliance data and lead periodic data-driven compliance reviews for senior leadership.
- Build AI literacy and apply approved AI tools in alignment with data governance, privacy, and responsible AI expectations.
- Lead oversight/governance for significant compliance escalations; align required actions and communications to senior leadership.
- Participate in regulatory compliance audits, due diligence, and acquisition compliance assessments; develop strategic plans and influence outcomes.
- 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.
Qualifications:
- Bachelor’s degree minimum.
- Advanced degree/certification preferred.
- 10+ years relevant quality and compliance experience required.
- Health Authority/Notified Body experience preferred (not required).
- Prior cGMP regulatory compliance experience in medical device and/or pharmaceutical regulations required.
- Strong written/oral communication; leadership track record; ability to influence without line authority; thrive in a complex matrix; up to 20% travel.
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/Services; Mentorship; Policy Development; Report Writing; Tactical Planning; Technical Credibility.
Benefits (time off, subject to policy/date of hire):
- Vacation: 120 hours/year; Sick: 40 hours/year (CO 48; WA 56)
- Holiday pay (incl. floating): 13 days/year
- Work/Personal/Family time: up to 40 hours/year
- Parental leave: 480 hours; Bereavement: 240 (immediate) / 40 (extended)
- Caregiver leave: 80 hours in a 52-week rolling period (listed as 10 days)
- Volunteer leave: 32 hours/year; Military spouse time-off: 80 hours/year