Senior Controlled Substance Compliance Lead (Quality/DEA)

6062-Janssen Pharmaceuticals, Inc. Legal Entity; Franklin Township (NJ); On-site; USD 102,000 - 177,000; Full time

Job summary

Janssen Pharmaceuticals, Inc. Legal Entity in Somerset, NJ is seeking a Commercial Quality Controlled Substance Manager to lead the controlled substance compliance program for the Somerset, NJ and Shepherdsville, KY facilities.

The role includes overseeing DEA inspections, regulatory reporting (ARCOS, DEA Forms 41/106/222, CSOS), and security, while ensuring cGMP and GDP compliance across distribution, clinical products, and sample programs.

Qualifications

• Minimum 6 years in controlled substance compliance or a related quality/regulatory role.
• Direct experience managing DEA regulatory requirements and inspections.
• Strong knowledge of DEA regulations, Title 21 CFR, and diversion monitoring.
• Experience interacting with federal/state regulators and cross-functional teams.

Responsibilities

• Lead DEA inspections, regulatory audits, and agency inquiries with preparatory activities.
• Oversee controlled substance security programs and regulatory documentation.
• Ensure quality systems compliance for distribution of controlled substances and clinical products.
• Provide strategic leadership on compliance risks and continuous improvement initiatives.

Skills

Controlled substance compliance

Regulatory compliance

Leadership

Cross-functional collaboration

Quality systems

Education

Bachelor's degree or equivalent

Tools

SAP

WMS

Master Data Systems

Job description

Janssen Pharmaceuticals, Inc. Legal Entity in Somerset, NJ is seeking a Commercial Quality Controlled Substance Manager to lead the controlled substance compliance program for the Somerset, NJ and Shepherdsville, KY facilities.

The role includes overseeing DEA inspections, regulatory reporting (ARCOS, DEA Forms 41/106/222, CSOS), and security, while ensuring cGMP and GDP compliance across distribution, clinical products, and sample programs.