Controlled Substance Manager

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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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.

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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 DEAregulated 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 DEAregulated activities related to the research use analysis importation exportation and distribution of controlled substances within Innovative Medicine R&D U.S.
  
• Managing the endtoend 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 crosssite team members.
  
• Conducting required inventories and coordinating compliant movement and chainofcustody 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 crossfunctional teams to ensure compliant operations.
  
• Maintaining continuous inspection readiness and lead continuous improvement initiatives.
  

Qualifications/Requirements

Education:

• A minimum of a Bachelors 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 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 crossfunctional partners is preferred.
  

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 external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

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