Director, External Manufacturing Compliance Oversight

Regulatory Jobs; Horsham (PA); On-site; USD 150,000 - 259,000; Full time

Benefits offered by this job

Long-term incentive program

Pension plan

401(k)

Job summary

Johnson & Johnson seeks a Director for External Manufacturing Regulatory Compliance Oversight to provide independent regulatory oversight across the manufacturing network. The role partners with Quality, Supply Chain, Regulatory Affairs, and Technical Operations to identify emerging risks and strengthen inspection readiness.

Leadership in a global, matrixed environment is essential to drive governance, CAPA effectiveness, and organizational learning while ensuring compliant partnerships with

Qualifications

• Bachelor's Degree in Life Sciences, Engineering, Pharmacy, or related scientific discipline.
• Advanced degree preferred.
• Minimum 12 years of pharmaceutical, biotechnology, biologics, advanced therapy, medical device, or combination product 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.
• Experience working in global and highly matrixed environments.

Responsibilities

• Provide independent regulatory compliance oversight across External Manufacturing partners.
• Strengthen governance, inspection readiness, and remediation effectiveness.
• Lead risk assessments, trend analyses, and escalation for significant compliance risks.
• Collaborate with cross-functional teams to drive compliance across the network.
• Coach and develop compliance professionals supporting External Manufacturing oversight.

Skills

Regulatory oversight

Executive communication

Risk management

Cross-functional leadership

Inspection readiness

Education

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

Advanced degree preferred

Job description

Johnson & Johnson seeks a Director for External Manufacturing Regulatory Compliance Oversight to provide independent regulatory oversight across the manufacturing network. The role partners with Quality, Supply Chain, Regulatory Affairs, and Technical Operations to identify emerging risks and strengthen inspection readiness.

Leadership in a global, matrixed environment is essential to drive governance, CAPA effectiveness, and organizational learning while ensuring compliant partnerships with