Commercial Quality Controlled Substance Manager

Johnson & Johnson

. Lead and maintain the controlled substance compliance program for JOM distribution centers in Somerset, NJ and Shepherdsville, KY.

Posted 10/6/2026full-timeUnited StatesMid-LevelSenior💰 $102,000 - $177,100 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in controlled substance compliance, including DEA regulations, regulatory audits, and quality oversight in pharmaceutical distribution. Proven ability to lead compliance initiatives, manage cross-functional teams, and ensure adherence to security and regulatory standards.

Highest-signal resume keywords

Controlled Substance ComplianceDEA Regulatory Requirements ManagementARCOS Reporting and DocumentationPharmaceutical Quality OversightRegulatory Agency Interaction

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Controlled Substance ComplianceDEA RegulationsARCOS ReportingSuspicious Order MonitoringRegulatory AuditsQuality Systems ManagementRisk AssessmentsInvestigationsChange ControlsPharmaceutical Distribution

Soft Skills

LeadershipCross-Functional CollaborationCoaching and DevelopmentContinuous ImprovementCommunication

Tools & Technologies

Microsoft OfficeSAPWMSMaster Data SystemsEDI DataIMS Data

Industry Keywords

Controlled Substance SecurityRegulatory CompliancePharmaceutical QualityDEA InspectionsClinical Management

Tech Stack

Tools & technologies

ERP

About the role

Key responsibilities & impact

Lead and maintain the controlled substance compliance program for JOM distribution centers in Somerset, NJ and Shepherdsville, KY.
Serve as the primary controlled substance compliance lead and subject matter expert for Commercial Quality.
Lead DEA, state, and international controlled substance compliance activities, including reporting, registrations, renewals, ARCOS submissions, DEA Forms 41, 106, and 222, CSOS transactions, and import/export permits.
Partner with the Controlled Substance Compliance Center of Excellence to resolve complex compliance matters and implement compliant business solutions.
Oversee controlled substance security programs, procedures, regulatory notifications, facility security enhancements, transportation requirements, and Supply Chain Security initiatives.
Lead DEA inspections, regulatory audits, assessments, agency inquiries, inspection readiness, responses, and remediation plans.
Liaise with DEA field offices, state agencies, customs authorities, and other regulatory bodies.
Lead diversion prevention, suspicious order monitoring, physical security controls, risk assessments, and regulatory risk management initiatives.
Lead investigations involving material losses, thefts, significant discrepancies, and potential diversion events.
Provide quality oversight for controlled substance, clinical, and sample product distribution, including receipt, storage, handling, fulfillment, disposition, returns, destruction, investigations, CAPAs, effectiveness checks, and change controls.
Support controlled substance new product introductions through assessments, registrations, system readiness, master data setup, and security evaluations.
Participate in Quality System Management Reviews and governance forums.
Escalate significant quality, compliance, security, and regulatory issues to leadership.
Build cross-functional partnerships with stakeholders, customers, suppliers, government agencies, health authorities, and industry partners.
Represent the organization in working groups and external forums.
Drive continuous improvement, inspection readiness, and risk-based quality and compliance decisions.
Support 24/7 distribution center operations and critical events.
Lead, coach, and develop a quality and compliance team.

Requirements

What you’ll need

A 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.
Prior experience leading, supporting, or participating in DEA inspections, audits, and regulatory interactions is required.
Experience preparing and submitting DEA regulatory reports and documentation, including ARCOS reporting, DEA Forms 41, 106, 222, CSOS transactions, registrations, and import/export permits is required.
Strong knowledge of DEA regulations, Title 21 CFR, controlled substance security requirements, suspicious order monitoring programs, and diversion investigations is required.
Experience interacting directly with federal and state regulatory agencies and responding to regulatory observations and findings is required.
Working knowledge of DEA and FDA regulations and quality systems is required.
Previous experience managing people is required.
Experience working with a cross-functional organization is required.
Experience in pharmaceutical distribution is strongly preferred.
Knowledge in Clinical and Sample management is preferred.
Experience with Microsoft Office and ERP systems, including SAP, WMS, and Master Data Systems, is preferred.
Experience with ARCOS, CSOS, EDI data (852, 867), IMS data, and Sales data is preferred.
Experience interpreting compliance requirements and regulations is preferred.
Ability to support 24/7 distribution center operations and critical events.
Up to 10% domestic travel may be required.

Benefits

Comp & perks

Participation in the Company’s consolidated retirement plan (pension)
Savings plan (401(k))
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year; Colorado residents – 48 hours; Washington residents – 56 hours
Holiday pay, including Floating Holidays – 13 days per calendar year
Work, Personal and Family Time – up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Up to 10% domestic travel