Senior Controlled Substances Quality & Compliance Lead

Johnson & Johnson Innovative Medicine; New Jersey; On-site; USD 102,000 - 177,000; Full time

Benefits offered by this job

Vacation – 120 hours / year

Sick time – 40 hours / year (states)

Holiday pay – 13 days / year

Parental Leave – 480 hours / year

Volunteer Leave – 32 hours / year

Job summary

Johnson & Johnson Innovative Medicine is seeking a Senior Commercial Quality Controlled Substance Manager to lead DEA compliance, regulatory reporting, and security programs for US and international operations. Location options include Somerset, NJ or Shepherdsville, KY.

You will drive complex investigations, manage audits, and ensure continuous improvement across quality and distribution processes while partnering with internal stakeholders and regulatory bodies.

Qualifications

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

Responsibilities

• Lead DEA inspections, regulatory audits, and agency inquiries with readiness and coordination.
• Oversee controlled substance security programs and related documentation and reporting.
• Provide strategic leadership for compliance programs including diversion prevention and risk management.
• Collaborate with cross-functional teams to ensure quality, compliance, and supply continuity.

Skills

Coaching

Compliance Management

Consulting

Continuous Improvement

Fact-Based Decision Making

ISO 9001

Performance Measurement

Process Improvements

Quality Control

Quality Management Systems

Quality Standards

Regulatory Environment

Stakeholder Engagement

SOP

Technical Credibility

Education

Bachelor's degree or equivalent

Tools

SAP

WMS

Master Data Systems

ARCOS

CSOS

EDI data

Job description

Johnson & Johnson Innovative Medicine is seeking a Senior Commercial Quality Controlled Substance Manager to lead DEA compliance, regulatory reporting, and security programs for US and international operations. Location options include Somerset, NJ or Shepherdsville, KY.

You will drive complex investigations, manage audits, and ensure continuous improvement across quality and distribution processes while partnering with internal stakeholders and regulatory bodies.