Director, Site Regulatory Compliance – Advanced Therapy

6046-JANSSEN SUPPLY GROUP, LLC. Legal Entity; Raritan (NJ); On-site; USD 150,000 - 259,000; Full time

Job summary

Johnson & Johnson seeks a Director of Site Regulatory Compliance in Raritan, NJ (also open to Horsham, PA or Malvern, PA) to lead independent regulatory compliance across Advanced Therapy manufacturing. The role requires deep expertise in autologous/allogeneic cell therapies, aseptic processing, data integrity, and governance.

You will influence senior leaders and drive continuous inspection readiness in a complex manufacturing environment.

Qualifications

• Bachelor’s degree in a scientific discipline; advanced degree preferred.
• 10+ years of pharmaceutical/biotech experience.
• 5+ years of leadership experience.
• Experience with FDA/EMA/MHRA/PMDA inspections and global health authority inspections.

Responsibilities

• Provide strategic site compliance leadership and independent regulatory compliance perspective on inspection readiness and regulatory risk.
• Drive enterprise thinking to connect site risks to platform and enterprise risks; promote risk identification and cross-site learning.
• Support implementation of enterprise compliance priorities and develop strong compliance talent.

Skills

Regulatory compliance leadership

Quality & Compliance Audit

Cross-functional partnership

Influencing & leadership

Education

Bachelor’s degree in Biotechnology, Biological Sciences, Pharmacy, Engineering, Microbiology, Chemistry

Advanced degree preferred

Job description

Johnson & Johnson seeks a Director of Site Regulatory Compliance in Raritan, NJ (also open to Horsham, PA or Malvern, PA) to lead independent regulatory compliance across Advanced Therapy manufacturing. The role requires deep expertise in autologous/allogeneic cell therapies, aseptic processing, data integrity, and governance.

You will influence senior leaders and drive continuous inspection readiness in a complex manufacturing environment.