Production Manager, Controlled Substance

Description

DEPARTMENT: 140 - Controls

REPORTS TO: VP of Operations

Job Summary

The Controlled Substance Production Manager at PharmaLink is responsible for the daily operations and oversight of the Controlled Substance Department within a reverse distribution facility. This role ensures regulatory compliance with the Drug Enforcement Administration (DEA) and state laws governing controlled substances, including storage, handling, distribution, and reporting. The manager oversees the Controls processing team and maintains the integrity of the controlled substances inventory.

This role is critical in maintaining adherence to DEA regulations, processing Standard Operating Procedures (SOPs), and regulatory compliance for controlled substances. The individual must demonstrate strong leadership and organizational skills, collaborating with Operations, Quality Assurance, HR, and other departments to ensure compliance and prevent risks related to controlled substances.

Key Responsibilities

• Prepare and submit required reports to the DEA, including ARCOS reports, DEA Form 222, DEA Form 41 (destruction), and biennial inventory reports.
  
  

Inventory Management & Documentation

• Oversee controlled substance inventories, ensuring accurate tracking, storage, and reconciliation of discrepancies.
• Maintain all required documentation for controlled substances, including shipping, receiving, destruction records, and ARCOS filings.
• Conduct regular internal inventory audits and biennial reporting to ensure accuracy and compliance with DEA inventory tracking standards.
  
  

Security & Risk Management

• Ensure security protocols are in place to prevent unauthorized access and diversion of controlled substances.
• Investigate and report any theft, loss, or misuse of controlled substances through the proper channels.
• Develop corrective action plans with the Quality Assurance team for any compliance gaps or security breaches.
  
  

Leadership & Team Supervision

• Overall management and mentoring of the Controlled Substance Department team, including Supervisor and Material Handlers, ensuring adherence to company policies and compliance standards.
• Collaborate with HR for recruiting, coaching, training, performance evaluations, and disciplinary actions.
• Provide training and education to staff on proper handling, documentation, and storage of controlled substances.
  
  

Requirements

Qualifications:

• Education: Bachelor’s degree in science or a related field is preferred.
• 5-7 years of experience in a pharmaceutical, reverse distribution, or distribution facility.
• 3-5 years of people management experience, including supervising teams.
• Experience in maintaining and controlling serialized pharmaceutical inventory
• Experience operating in a cGMP environment preferred.
• Experience with change control systems, compliance audits, and regulatory reporting.
  
  

Skills

• Strong leadership and supervisory skills with the ability to coach and mentor teams.
• Ability to create, improve and sustain processes and systems to improve inventory accuracy and compliance.
• Excellent organizational skills with attention to detail and the ability to multitask in a fast-paced environment.
• Familiarity with Microsoft Office (Word, Excel, PowerPoint) and inventory management software.
• Strong verbal and written communication skills, with the ability to interact with various departments and regulatory agencies.
• Problem-solving and analytical skills to identify risks and implement corrective actions.
• Ability to maintain confidentiality and handle sensitive information responsibly.
  
  

Certifications (Preferred But Not Required)

• Lean Six Sigma Green Belt
• Certified Compliance and Ethics Professional (CCEP)
  
  

Additional Information

This position requires a hands-on leader with deep knowledge of inventory control and a strong ability to maintain compliance within a controlled substance environment. The Controlled Substance Manager will play a key role in ensuring the integrity of the inventory, preventing drug diversion, and safeguarding PharmaLink’s reputation in the pharmaceutical industry.

Physical Requirements

This position typically operates in an office environment with standard office hours. Flexibility in hours may be required during peak periods, such as month-end and year-end closings, as well as during audit cycles.

Relationships

In performing the above responsibilities, the Controlled Substance Manager maintains the following relationships:

The incumbent is accountable to the VP of Operations for interpreting and fulfilling the above responsibilities and others, which may be assigned.

As a service organization with a commitment to quality, it is the responsibility of each employee to maintain accurate and professional demeanor with colleagues and customers.

PharmaLink reserves the right to revise or change job duties and responsibilities as the need arises.

Note: Please submit your request in writing to Human Resources if you wish to discuss reasonable accommodations to help you perform the essential functions of this job.