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:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Biological Research

Job Category:

Scientific/Technology

All Job Posting Locations:

Spring House, Pennsylvania, 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 a Controlled Substance Manager, Automation & Screening Operations to located in Spring House, PA.
 

Purpose: 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.
   

Qualifications/Requirements

Education:

• A minimum of a Bachelor's degree is required. An advanced degree is preferred.
   

Experience and Skills:

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.
   

Preferred:

• Experience leading a small, geographically dispersed team in a matrixed