Jobs and Careers

Manager, Controlled Substances Compliance

Mallinckrodt

United Statesfull_timeVerifiedPosted 14 Apr 2025

About the role

Job Title

Requisition

JR000014914 Manager, Controlled Substances Compliance (Open)

Location

Hobart, NY

Additional Locations

Job Description Summary

Job Description

The Manager of Controlled Substances Compliance oversees and continuously monitors complex processes related to the handling of controlled substances, including receiving, storage, transportation, inventory control, destruction, quota management, and the implementation of a robust suspicious order monitoring and reporting system. This role ensures compliance with all relevant federal and state regulations. The Manager leads the Controlled Substances Compliance team at the Hobart site and serves as the site’s subject matter expert (SME) on DEA regulatory compliance, offering guidance and support to management, supervisors, and staff.

Essential Functions

Quota Requests:

Oversees quota requests to DEA for the Hobart plant and managing that quota with the corporate commercial, procurement and logistics teams throughout the year.
Reviews and communicates information for quota requests in support of the S&OP and Plant Performance Review processes.
Monitors quota consumption by interfacing with Manufacturing and Logistics.

Maintenance of Required DEA & State Compliance Records

Ensures DEA 222 Forms & required records are completed accurately and on time.
Ensures DEA ARCOS, CSOS and Year-End reports are completed on time and within guidelines.
Ensures completion of monthly, quarterly and annual reports for submission to Regulatory entities, i.e. state sales reporting and annual OSA reports.
Manages the review of controlled substance manufacturing/packaging records and forms to ensure accountabilities for all controlled substance materials during conversion from raw materials into finished product.
Oversees the DEA permit process for imports and exports of controlled substances.
Manages discrepancy investigations, and the filing of DEA106 reports as needed.
Conducts customer complaint investigations in conjunction with Security Director.
Primary POC for DEA and state-controlled substance inspections.
Ensures Hobart Site is audit prepared at all times.
Primary DEA Contact for Hobart Site DEA licenses and files for annual renewals.
Ensures a complete and accurate inventory at all times including execution of the year-end physical inventory for Manufacturing and Distribution in conjunction with Finance and Materials Management
Generate DEA Biennial Inventory Reports according to DEA regulations.
Ensures accurate and timely destruction of controlled substances dispositioned as waste.
Conducts serial number and lot trace reporting as required.

Controlled Substance Destruction:

Manages destruction of controlled substances with internal clients.

Suspicious Order Monitoring (SOM) program

As needed, reviews direct customer orders flagged for review and participates in a multi-level process to evaluate and recommend disposition of the order in accordance with company policy
Member of the Suspicious Order Monitoring Team (SOMT) that makes chargeback restriction decisions relative to indirect customers.
Ensures State SOM reporting requirements are met in accordance with state regulations.

Standard Operating Procedures (SOP)

Author, update and periodically review SOPs as needed to ensure compliance with DEA Regulations.

Minimum Requirements

Bachelor's Degree preferred. Equivalent education & experience will be considered
10+ years’ experience within the pharmaceutical industry, preferably in the area of manufacturing, quality assurance or regulatory compliance with emphasis on Controlled Substances Compliance.
Prior experience in interpreting and implementing DEA controlled substance regulatory requirements during all aspects of pharmaceutical manufacturing and distribution.
Auditing experience a plus
Must be available to work onsite 5 days/week

Benefit: