Director, Site Regulatory Compliance Advanced Therapy
Johnson & Johnson
Johnson & Johnson seeks a Director of Site Regulatory Compliance for advanced therapy manufacturing facilities in New Jersey or Pennsylvania. This senior leadership role oversees compliance strategy, regulatory risk management, inspection readiness, and team development across cell and gene therapy operations.
Responsibilities
- Provide independent regulatory compliance leadership and perspective on inspection readiness and regulatory risk across the site
- Oversee continuous inspection readiness for advanced therapy operations including aseptic manufacturing, chain of identity and custody, and manufacturing execution systems
- Develop and lead site-based regulatory compliance team; coach leaders on risk-based decision-making and inspection readiness
- Drive enterprise-wide risk identification, escalation, and cross-site learning to connect significant site risks to platform priorities
- Support visibility, prioritization, and governance of compliance risks including data integrity, validation, technology transfer, and supply continuity
Requirements
- Bachelor's degree in biotechnology, biological sciences, pharmacy, engineering, microbiology, chemistry, or related field
- 10+ years of pharmaceutical or biotechnology industry experience
- 5+ years of leadership and team management experience
- Significant experience in biologics manufacturing operations, quality, compliance, or regulatory oversight
- Experience supporting FDA, EMA, MHRA, or PMDA inspections and global regulatory inspections
- Knowledge of cell therapy manufacturing including autologous and allogeneic operations
Vacancy posted 8 days ago
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