Commercial Quality Controlled Substance Manager

Job Sub Function:
Customer/Commercial Quality

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at

We are searching for the best talent for Commercial Quality Controlled Substance Manager to be located at Somerset, NJ or Shepherdsville, KY. The Commercial Quality Controlled Substance Manager is responsible for leading and maintaining the controlled substance compliance program for JOM Distribution Centers located in Somerset, NJ and Shepherdsville KY , ensuring full compliance with all applicable Drug Enforcement Agency (DEA), Food and Drug Administration (FDA), Transportation Security Administration (TSA), federal, state, and local regulatory requirements are followed.

This role serves as the primary subject matter expert for controlled substance regulations, security, reporting, registrations, import/export activities, and suspicious order monitoring. The position is responsible for leading regulatory inspections, managing interactions with DEA and state agencies, ensuring inspection readiness, and providing strategic guidance to distribution operations and leadership on controlled substance compliance risks and requirements. In addition, the Manager, will be responsible for providing oversight for the distribution of controlled substance products, clinical products, and sample product programs ensuring compliance with applicable cGMP and GDP-related quality systems and processes, including but not limited to investigations, CAPAs, e-checks, change controls, storage, handling, distribution, returns and destruction activities.

Serve as the Primary Controlled Substance Compliance Lead for Commercial Quality (CQ) Deliver supporting JOM Pharmaceutical distribution and logistics operations, providing strategic oversight of controlled substance compliance programs across all applicable sites. Lead and oversee all DEA, state, and international controlled substance compliance activities, including regulatory reporting, registrations, renewals, ARCOS submissions, DEA Forms 41, 106, and 222, CSOS transactions, import/export permits, and related regulatory documentation.

Ensure uninterrupted supply and full compliance for domestic and international controlled substance movements. Partner closely with the Controlled Substance Compliance Center of Excellence (CoE) to resolve complex compliance matters, interpret evolving regulatory requirements, and implement compliant business solutions. Maintain robust controls and tracking systems to ensure accurate and timely completion of all required controlled substance documentation, transactions and reporting. Provide leadership and oversight for controlled substance security programs, including development and maintenance of security procedures, regulatory notifications, facility security enhancements, controlled substance transportation requirements, and compliance with J&J Global Security standards and Supply Chain Security initiatives.

Lead and manage DEA inspections, regulatory audits, assessments, and agency inquiries, including inspection readiness, preparation activities, onsite support, response development, and remediation plans. Serve as the primary liaison with DEA field offices, state regulatory agencies, customs authorities, and other regulatory bodies, representing the organization during inspections, investigations, compliance reviews, and enforcement-related activities. Provide strategic leadership for controlled substance compliance programs, including 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. Ensure timely reporting, escalation, and regulatory communication, including DEA Form 106 submissions and coordination with J&J Global Security. Provide quality oversight for the distribution of controlled substances,…