Controlled Substance Quality & Compliance Manager

Johnson & Johnson Innovative Medicine; Shepherdsville (KY); On-site; USD 102,000 - 177,000; Full time

Benefits offered by this job

Vacation – 120 hours/year

Sick time – 40 hours/year

Holiday pay

Job summary

Johnson & Johnson is seeking a Commercial Quality Controlled Substance Manager to locate in Somerset, NJ or Shepherdsville, KY. You will lead DEA and state compliance activities, ensure secure handling of controlled substances, and coordinate with global security and quality teams.

The role requires 6+ years in regulated pharma quality and strong expertise in DEA regulations, ARCOS reporting, and cross-functional collaboration to maintain inspection readiness and supply continuity.

Qualifications

• Bachelor's degree or equivalent combination of experience and education is required.
• Minimum of 6 years of experience in controlled substance compliance, pharmaceutical quality, regulatory compliance, or a related highly regulated industry is required.
• Direct experience managing DEA regulatory requirements for controlled substances is required.
• Experience leading DEA inspections, audits, and regulatory interactions is required.
• Strong knowledge of DEA regulations, Title 21 CFR, controlled substance security requirements, and diversion investigations is required.

Responsibilities

• Serve as the Primary Controlled Substance Compliance Lead for CQ Deliver, overseeing distribution and logistics operations.
• Lead DEA, state, and international controlled substance compliance activities, including reporting and registrations.
• Coordinate with the CoE to resolve complex compliance matters and implement compliant solutions.
• Provide leadership for controlled substance security programs and enforcement actions including inspections.
• Lead investigations involving losses, thefts, and diversion events; ensure regulatory reporting.

Skills

Coaching

Compliance Management

Continuous Improvement

Regulatory Environment

Stakeholder Engagement

SOP

Quality Management Systems

Quality Standards

Education

Bachelor's degree or equivalent

Tools

SAP

WMS

Master Data Systems

Job description

Johnson & Johnson is seeking a Commercial Quality Controlled Substance Manager to locate in Somerset, NJ or Shepherdsville, KY. You will lead DEA and state compliance activities, ensure secure handling of controlled substances, and coordinate with global security and quality teams.

The role requires 6+ years in regulated pharma quality and strong expertise in DEA regulations, ARCOS reporting, and cross-functional collaboration to maintain inspection readiness and supply continuity.