Director, External Manufacturing Compliance & Oversight

Johnson & Johnson; Horsham (PA); On-site; USD 180,000 - 240,000; Full time

Job summary

Johnson & Johnson seeks a Director, External Manufacturing Regulatory Compliance Oversight in the US. This role provides independent oversight across the External Manufacturing network, partnering with Quality, Regulatory Affairs and Operations to strengthen compliance and readiness.

Travel up to 25-40% globally. The position emphasizes governance, risk assessment, and remediation, supporting continuous improvement and lessons learned across contract manufacturers and external laboratories.

Qualifications

• Minimum 12 years of GMP experience in pharma/biotech/medical devices.
• 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.
• Experience with CMO oversight, inspection readiness, CAPA governance, risk management, and quality systems.
• Strong understanding of global GMP regulations and external manufacturing compliance requirements.

Responsibilities

• Provide independent regulatory compliance oversight across External Manufacturing network.
• Identify emerging compliance risks and provide objective assessment.
• Support inspection readiness activities and risk-based assessments.
• Review regulatory commitments, remediation plans, and inspection responses.
• Lead, coach, and develop compliance professionals.
• Partner with cross-functional teams to influence compliance outcomes.

Skills

Leadership

Executive communication

Analytical thinking

Cross-functional collaboration

Influence without authority

Education

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

Advanced degree preferred

Job description

Johnson & Johnson seeks a Director, External Manufacturing Regulatory Compliance Oversight in the US. This role provides independent oversight across the External Manufacturing network, partnering with Quality, Regulatory Affairs and Operations to strengthen compliance and readiness.

Travel up to 25-40% globally. The position emphasizes governance, risk assessment, and remediation, supporting continuous improvement and lessons learned across contract manufacturers and external laboratories.