Controlled Substances Compliance Lead

Johnson Johnson; New Jersey; Presencial; USD 120.000 - 170.000; Jornada completa

Descripción de la vacante

Johnson & Johnson in Somerset, NJ seeks a Commercial Quality Controlled Substance Manager to lead the controlled substance program across the JOM distribution centers in Somerset, NJ and Shepherdsville, KY. You will ensure DEA/FDA drug regulations compliance and readiness for inspections.

You will partner with the CoE, manage registrations, reports, ARCOS, 222 forms, CSOS, and implement secure handling, storage, distribution and destruction in line with cGMP and GDP quality systems.

Formación

• Experience leading controlled substance compliance programs.
• Knowledge of DEA forms, ARCOS, CSOS, and reporting.
• Experience coordinating regulatory inspections and audits.
• Understanding of cGMP and GDP-related quality systems.

Responsabilidades

• Serve as the Primary Controlled Substance Compliance Lead for Commercial Quality, delivering oversight of programs across sites.
• Lead and oversee DEA, state and international compliance activities, including reporting, registrations and related documentation.
• Partner with the Compliance Center of Excellence to resolve complex matters and implement compliant business solutions.
• Provide leadership for controlled substance security programs, including procedures, notifications and security enhancements.
• Lead DEA inspections, regulatory audits, assessments and inquiries, including readiness and remediation plans.
• Act as the liaison with DEA field offices and regulatory bodies during inspections and reviews.

Conocimientos

Controlled substance compliance

DEA regulations

Regulatory reporting

Inspection readiness

Security programs

Leadership

Regulatory inspections coordination

Descripción del empleo

Johnson & Johnson in Somerset, NJ seeks a Commercial Quality Controlled Substance Manager to lead the controlled substance program across the JOM distribution centers in Somerset, NJ and Shepherdsville, KY. You will ensure DEA/FDA drug regulations compliance and readiness for inspections.

You will partner with the CoE, manage registrations, reports, ARCOS, 222 forms, CSOS, and implement secure handling, storage, distribution and destruction in line with cGMP and GDP quality systems.