Global Director, External Manufacturing Compliance

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

Job summary

Johnson & Johnson Innovative Medicine seeks a Senior Director of External Manufacturing Regulatory Compliance Oversight to lead enterprise-wide compliance, risk visibility, and inspection readiness across the External Manufacturing network.

The role partners with Quality, Regulatory Affairs, Supply Chain, and Technology teams to pro-actively identify compliance risks, guide remediation, and foster a culture of governance and continuous improvement across locations in Horsham, Malvern, Spring

Qualifications

• Minimum 15 years of pharmaceutical/biotech GMP experience.
• Minimum 10 years of leadership in Quality, Compliance, Regulatory Compliance, External Manufacturing, or supplier oversight.
• Experience leading global compliance or oversight programs involving external manufacturing partners.

Responsibilities

• Develop and mature the IMRC External Manufacturing compliance oversight strategy in alignment with IMRC objectives and Innovative Medicine priorities.
• Define risk-based principles and expectations for independent compliance oversight across contract manufacturers, contract laboratories, strategic partners, critical suppliers, and other outsourced operations.
• Maintain enterprise visibility of significant External Manufacturing compliance risks, inspection-readiness concerns, remediation themes, and emerging signals.
• Provide an independent compliance perspective on new partnerships, acquisitions, technology transfers, product launches, and network changes.
• Promote consistency across platforms while recognizing differences in product, technology, lifecycle stage, and business model.
• Serve as the primary compliance liaison for external manufacturing across: External Manufacturing Operations, Supply Chain, Procurement, Quality, Regulatory Affairs, Product Development, Technical Operations, Manufacturing Science & Technology, and partner with platform compliance leaders to ensure consistent application of compliance standards.

Skills

Leadership experience

Regulatory compliance

GMP experience

External Manufacturing oversight

Cross-functional collaboration

Education

Bachelor’s degree

Advanced degree

Job description

Johnson & Johnson Innovative Medicine seeks a Senior Director of External Manufacturing Regulatory Compliance Oversight to lead enterprise-wide compliance, risk visibility, and inspection readiness across the External Manufacturing network.

The role partners with Quality, Regulatory Affairs, Supply Chain, and Technology teams to pro-actively identify compliance risks, guide remediation, and foster a culture of governance and continuous improvement across locations in Horsham, Malvern, Spring