Controlled Substance Manager

Johnson & Johnson Innovative Medicine • Spring House, PA

2d • Onsite

About The Position

The Controlled Substance Manager will be responsible for the oversight, governance, and execution of all DEA‑regulated activities supporting Innovative Medicine R&D U.S. operations. This role ensures full lifecycle compliance for controlled substances, maintains continuous inspection readiness, and provides leadership and oversight across multiple U.S. sites. You will be responsible for: Providing oversight and operational leadership for all DEA‑regulated activities related to the research use, analysis, importation, exportation, and distribution of controlled substances within Innovative Medicine R&D U.S. Managing the end‑to‑end lifecycle of controlled substances, including licensing, procurement, recordkeeping, chain of custody, shipment, and reverse distribution. Serving as the primary company representative and subject matter expert (SME) for interactions with federal and state regulatory agencies, including DEA audits, inspections, and inquiries. Acting as the DEA Program Coordinator for Innovative Medicine R&D sites, with governance oversight of the Controlled Substances program and cross‑site team members. Conducting required inventories and coordinating compliant movement and chain‑of‑custody transfers. Developing, implementing, and maintaining effective processes, controls, and procedures to ensure accountability and traceability of controlled substances. Ensuring rapid and compliant integration of new sites into Innovative Medicine R&D systems and controlled substance compliance programs. Partnering with cross‑functional teams to ensure compliant operations. Maintaining continuous inspection readiness and lead continuous improvement initiatives.

Requirements

• A minimum of a Bachelor's degree is required.
• A minimum of 10 years of experience handling or managing DEA controlled substances is required.
• Demonstrated experience managing controlled substances in a pharmaceutical R&D, manufacturing, or equivalent regulated environment.
• Strong working knowledge of DEA regulations and their application in pharmaceutical R&D is required.
• Ability to travel to other U.S. Innovative Medicine R&D sites as needed, including responding to unscheduled DEA inspections in less than 24-hour time frame, is required.

Nice To Haves

• An advanced degree is preferred.
• Experience leading a small, geographically dispersed team in a matrixed organization is preferred.
• Ability to adapt to changing priorities and business needs in a dynamic, regulated environment is preferred.
• Proficiency with inventory management and controlled substance compliance systems is preferred.
• Demonstrated initiative in continuous learning and professional development is preferred.
• Strong communication skills and ability to work effectively with regulators, leadership, and cross‑functional partners is preferred.

Responsibilities

• Providing oversight and operational leadership for all DEA‑regulated activities related to the research use, analysis, importation, exportation, and distribution of controlled substances within Innovative Medicine R&D U.S.
• Managing the end‑to‑end lifecycle of controlled substances, including licensing, procurement, recordkeeping, chain of custody, shipment, and reverse distribution.
• Serving as the primary company representative and subject matter expert (SME) for interactions with federal and state regulatory agencies, including DEA audits, inspections, and inquiries.
• Acting as the DEA Program Coordinator for Innovative Medicine R&D sites, with governance oversight of the Controlled Substances program and cross‑site team members.
• Conducting required inventories and coordinating compliant movement and chain‑of‑custody transfers.
• Developing, implementing, and maintaining effective processes, controls, and procedures to ensure accountability and traceability of controlled substances.
• Ensuring rapid and compliant integration of new sites into Innovative Medicine R&D systems and controlled substance compliance programs.
• Partnering with cross‑functional teams to ensure compliant operations.
• Maintaining continuous inspection readiness and lead continuous improvement initiatives.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees