Director, External Manufacturing Regulatory Compliance Oversight
Johnson & Johnson · Horsham, PA +4 more
RegulatoryFull-time$150k–$259kCompany career page
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Role summary
Johnson & Johnson seeks a Director to provide independent regulatory compliance oversight across external manufacturing partners. The role monitors compliance risks, supports inspection readiness, and drives organizational learning to strengthen performance across the contract manufacturing network.
What they're looking for
- Extensive regulatory compliance experience in pharmaceutical manufacturing or external manufacturing oversight
- Demonstrated expertise in health authority inspections and compliance assessment methodologies
- Strong knowledge of FDA regulations, GMP requirements, and pharmaceutical quality standards
- Leadership experience managing compliance programs and cross-functional stakeholder engagement
- Proven ability to conduct independent risk assessments and provide objective compliance recommendations
- Experience with CAPA processes, root cause analysis, and remediation effectiveness evaluation
What you'll be doing
- Monitor and assess significant compliance risks across assigned external manufacturing partners
- Conduct independent risk assessments and provide objective compliance challenge to operations teams
- Provide oversight of inspection readiness activities, mock inspections, and regulatory responses
- Evaluate corrective and preventive actions for effectiveness and sustainability of remediation
- Facilitate deployment of inspection learnings and best practices across the external manufacturing network
Privacy & handoff
This role links to Johnson & Johnson's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.