Director, External Manufacturing Compliance & Oversight

Johnson & Johnson; Leiden; On-site; EUR 160,000 - 280,000; Full time

Job summary

Johnson & Johnson is seeking a Director, External Manufacturing Regulatory Compliance Oversight to provide independent regulatory oversight across the IM External Manufacturing network. You will partner with operations, quality, regulatory affairs, and supply chain to identify risks, strengthen compliance, and support proactive remediation.

You will lead governance forums, drive inspection readiness, and deploy organizational learning to improve regulatory performance across contract

Qualifications

• Bachelor's Degree in Life Sciences, Engineering, Pharmacy, or related scientific discipline.
• Minimum 12 years of pharmaceutical GMP experience.
• Minimum 5 years of leadership experience in Quality, Compliance, Regulatory Compliance, Supplier Quality, or External Manufacturing.
• Experience supporting Health Authority inspections, remediation programs, and supplier oversight activities.
• Demonstrated experience with CMO oversight, inspection readiness, CAPA governance, risk management, and quality systems.

Responsibilities

• Provide independent regulatory compliance oversight of contract manufacturers, contract laboratories, external sterilization providers, critical suppliers, and strategic partners.
• Assess whether oversight approaches appropriately reflect partner risk, product complexity, regulatory history, and business criticality.
• Review compliance trends related to inspections, deviations, complaints, investigations, CAPAs, and supplier performance.
• Challenge the adequacy of risk mitigation plans and remediation strategies.
• Support compliance evaluations associated with new partnerships, technology transfers, product launches, and network changes.

Skills

Regulatory compliance

GMP experience

Leadership

Risk management

Global collaboration

Inspection readiness

Quality systems

Education

Bachelor's Degree in Life Sciences, Engineering, Pharmacy, or related scientific discipline

Advanced degree preferred

Job description

Johnson & Johnson is seeking a Director, External Manufacturing Regulatory Compliance Oversight to provide independent regulatory oversight across the IM External Manufacturing network. You will partner with operations, quality, regulatory affairs, and supply chain to identify risks, strengthen compliance, and support proactive remediation.

You will lead governance forums, drive inspection readiness, and deploy organizational learning to improve regulatory performance across contract