Commercial Quality Controlled Substance Manager

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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.
• 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, clinical, and sample products, ensuring compliance with applicable cGMP and GDP-related quality systems and processes, including product receipt, storage, handling, distribution, order fulfillment, product disposition, returns, destruction activities, and Quality Event Management (QEM) records, including investigations, CAPAs, effectiveness checks, and change controls.
• Support Controlled Substance New Product Introductions (NPI) through product assessments, registration activities, system readiness reviews, master data setup, and facility security evaluations to ensure compliant and successful product launches.
• Participate in Quality System Management Reviews (QSMRs) and other governance forums, providing visibility on quality, compliance, regulatory, related to controlled substance, clinical and sample business.

• Escalate significant quality, compliance, security, or regulatory issues to leadership in accordance with company procedures and established governance requirements.
• Ensure timely communication/reporting/escalation to the districts on any material losses (Form 106) or diversions. Lead any potential diversion investigations in partnership with J&J Global Security.

• Build and maintain strong cross-functional partnerships with internal stakeholders and business partners.
• Establish and maintain effective relationships with customers, suppliers, government agencies, health authorities, regulatory bodies, and industry partners.
• Represent the CQ Deliver organization for in working groups, and external forums to remain informed of emerging regulations, industry trends, and evolving best practices impacting controlled substance and distribution operations.
• Drive the identification and implementation of continuous improvement initiatives to strengthen quality, compliance, operational effectiveness, and inspection readiness.
• Make risk-based quality and compliance decisions that effectively balance business needs, regulatory requirements, patient safety, and supply continuity.
• Support 24/7 distribution center operations and provide leadership during critical compliance, regulatory, security, and operational events.
• Lead, coach, and develop a high-performing quality and compliance team, fostering a culture of accountability, continuous improvement, employee engagement, and regulatory.

Qualifications

Education:

• A Bachelor's degree or equivalent combination of experience and education is required.

Experience:

• 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.
• Demonstrated 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 & 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 working with Microsoft Office and ERP systems (i.e. SAP, WMS, Master Data Systems, etc.) preferred.
• Experience working with ARCOS ,CSOS, EDI data (852, 867), IMS data and Sales data is preferred.
• Experience interpreting compliance requirements and regulations is preferred.

Other:

• This position could require up to 10% of domestic travel.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. 

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

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