Commercial Quality Controlled Substance Manager

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Customer/Commercial Quality

Job Category:

Professional

All Job Posting Locations:

Shepherdsville, Kentucky, United States of America, Somerset, New Jersey, United States of America

Job Description:

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 https://www.jnj.com/innovative-medicine

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.

Key Responsibilities:

• 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.

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