Senior Director, External Manufacturing Regulatory Compliance

Johnson & Johnson Innovative Medicine; Horsham (PA); On-site; USD 200,000 - 260,000; Full time

Job summary

Johnson & Johnson in Horsham, PA seeks a Senior Director to oversee Regulatory Compliance for its external manufacturing network. This leadership role drives risk-based strategies, ensures inspection readiness, and provides independent oversight across global partners.

The candidate will collaborate with Quality, Regulatory, Supply Chain and Development functions and act as the primary liaison for external manufacturing oversight programs.

Qualifications

• Bachelor's degree in life sciences, engineering, pharmacy or related.
• 15+ years in GMP pharmaceutical, biotech, or biologics sectors.
• 10+ years in leadership, supplier oversight, or regulatory compliance, with global inspection experience.

Responsibilities

• Develop and oversee risk-based compliance strategies for external manufacturing.
• Ensure inspection readiness across the external manufacturing network.
• Provide independent oversight and risk assessments.
• Promote organizational learning across global partners in manufacturing and supply chain.
• Collaborate with Quality, Regulatory, Supply Chain and Development; serve as primary compliance liaison.

Skills

Leadership

Regulatory compliance

GMP knowledge

Risk management

Inspection readiness

Cross-functional collaboration

Supplier oversight

Education

Bachelor's degree in life sciences, engineering, pharmacy or related

Job description

Role

Senior Director, External Manufacturing Regulatory Compliance Oversight, leading enterprise-level compliance for Johnson & Johnson's external manufacturing network.

Responsibilities

• develop and oversee risk-based compliance strategies
• ensure inspection readiness
• provide independent oversight and risk assessments
• promote organizational learning across global manufacturing and supply chain partners
• Collaborate with Quality, Regulatory, Supply Chain, and Development functions; serve as primary compliance liaison for external manufacturing and oversight programs.

Requirements

• Bachelor's in life sciences, engineering, pharmacy or related
• 15+ years in GMP pharmaceutical, biotech, or biologics sectors
• 10+ years in leadership, supplier oversight, or regulatory compliance, with global inspection experience

HighValue

• extensive GMP expertise
• supplier quality systems
• risk management
• inspection readiness
• oversight of CMOs and strategic manufacturing partners
• regulatory interactions, and governance

WorkSetup

global, cross-functional, senior leadership role.