Director, Enterprise Regulatory Compliance
Johnson & Johnson
September 03, 2026
Remote friendly (Cornelia, GA)
United States
Corporate Functions
Director, Enterprise Regulatory Compliance (Enterprise Regulatory Compliance Assessment)
Key Responsibilities:
- Serve as Enterprise Regulatory Compliance single point of contact and subject-matter leader for policy interpretation, issue triage, and decision support across pharma 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.
- Review/initiate issue management for 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 to requirements.
- Analyze regulatory compliance data and lead periodic data-driven compliance reviews for senior executives.
- Build AI literacy and use approved AI tools to improve analysis, synthesis, documentation, and quality checks (aligned with governance/privacy/responsible AI).
- Lead oversight/governance for significant compliance escalations and coordinate required actions/communications.
- Support audits, due diligence, and acquisition compliance assessments; develop strategic plans aligned to enterprise objectives.
- Provide consultative expertise on compliance issue management and health authority responses/field action decisions.
- Deliver cGMP training on risk-based auditing strategies.
Qualifications:
- Bachelor’s degree required; advanced degree/certification preferred.
- 10+ years relevant quality and compliance experience required.
- Prior cGMP regulatory compliance experience in medical device and/or pharma required.
- Health Authority/Notified Body experience preferred.
- Strong written/oral communication; leadership track record in cGMP compliance; ability to influence cross-culturally and across all org levels; thrive in complex matrix.
- Up to 20% domestic/international travel.
Preferred Skills:
Advanced Analytics; Audit and compliance trends; compliance management/risk; confidentiality; controls compliance; internal auditing; investigation techniques; policy development; report writing; tactical planning; technical credibility; mentoring/developing others.
Benefits (time off): Vacation (120 hrs/yr); Sick time (40 hrs/yr; CO:48; WA:56); Holiday incl. floating (13 days/yr); Work/Personal/Family Time (up to 40 hrs/yr); Parental Leave (480 hrs within one year); Bereavement (240 hrs immediate; 40 hrs extended); Caregiver Leave (80 hrs/52 weeks; incl. 10 days); Volunteer Leave (32 hrs/yr); Military Spouse Time-Off (80 hrs/yr).
Key Responsibilities:
- Serve as Enterprise Regulatory Compliance single point of contact and subject-matter leader for policy interpretation, issue triage, and decision support across pharma 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.
- Review/initiate issue management for 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 to requirements.
- Analyze regulatory compliance data and lead periodic data-driven compliance reviews for senior executives.
- Build AI literacy and use approved AI tools to improve analysis, synthesis, documentation, and quality checks (aligned with governance/privacy/responsible AI).
- Lead oversight/governance for significant compliance escalations and coordinate required actions/communications.
- Support audits, due diligence, and acquisition compliance assessments; develop strategic plans aligned to enterprise objectives.
- Provide consultative expertise on compliance issue management and health authority responses/field action decisions.
- Deliver cGMP training on risk-based auditing strategies.
Qualifications:
- Bachelor’s degree required; advanced degree/certification preferred.
- 10+ years relevant quality and compliance experience required.
- Prior cGMP regulatory compliance experience in medical device and/or pharma required.
- Health Authority/Notified Body experience preferred.
- Strong written/oral communication; leadership track record in cGMP compliance; ability to influence cross-culturally and across all org levels; thrive in complex matrix.
- Up to 20% domestic/international travel.
Preferred Skills:
Advanced Analytics; Audit and compliance trends; compliance management/risk; confidentiality; controls compliance; internal auditing; investigation techniques; policy development; report writing; tactical planning; technical credibility; mentoring/developing others.
Benefits (time off): Vacation (120 hrs/yr); Sick time (40 hrs/yr; CO:48; WA:56); Holiday incl. floating (13 days/yr); Work/Personal/Family Time (up to 40 hrs/yr); Parental Leave (480 hrs within one year); Bereavement (240 hrs immediate; 40 hrs extended); Caregiver Leave (80 hrs/52 weeks; incl. 10 days); Volunteer Leave (32 hrs/yr); Military Spouse Time-Off (80 hrs/yr).