Director, External Manufacturing Regulatory Compliance Oversight

Johnson & Johnson

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.

Responsibilities

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

Requirements

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

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Vacancy posted 5 days ago

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