Manager, Controlled Substances Compliance

Job Title

Requisition

Location

Additional Locations

Job Description Summary

Job Description

The Manager, Controlled Substances Compliance is responsible for continually monitoring complex issues pertaining to processes and procedures for controlled substance receiving, storing, transporting, inventory control, drug destruction, quota management and managing an effective suspicious order monitoring and reporting system in compliance with applicable federal and state laws/regulations. Additionally, as the site SME for DEA regulatory compliance, the Manager will provide support and guidance to management, supervisors and employees.

Quota Requests:

• Responsible for requesting quota from DEA for the Fenton plant and managing that quota with the corporate commercial, procurement and logistics teams throughout the year.

• Assembles information for quota requests in support of the S&OP process.

• Monitors quota consumption by interfacing with Manufacturing and Logistics.

Maintenance of Required DEA Records

• Ensures DEA 222 Forms & required records are completed accurately and on time.

• Ensures DEA ARCOS reports are completed on time and within guidelines.

• Ensures completion of quarterly and annual reports for submission to DEA.

• Manages the review of controlled substance manufacturing/ packaging records 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.

• Primary POC for DEA and state-controlled substance inspections.

Controlled Substance Destruction:

• Manages and maintains the physical inventory of unusable controlled substance material received from production, customers, carriers, outside warehouses, QA, and R&D.

• Manages destruction of controlled substances with internal clients by performing verification and coordination of controlled substance destruction; corresponds with local DEA office to schedule destructions and forward completed DEA Form 41s.

Suspicious Order Monitoring (SOM) program

• Member of the Suspicious Order Monitoring Team (SOMT) that makes chargeback restriction decisions relative to indirect customers.

Licensure

• Ensures applications for renewal of DEA registration is submitted in a timely manner.

• High School diploma or equivalent.

• 5+ years' experience within the pharmaceutical industry, preferably in the area of manufacturing, quality assurance or regulatory compliance.

• Experience in interpreting and implementing the regulatory requirements associated with the use of controlled substance materials during all aspects of the pharmaceutical manufacturing and distribution.

Attention to Detail: Is thorough and precise in accomplishing a task through concern for all the areas involved, no matter how small; monitors and checks work or information and plans and organizes time and resources efficiently; double-checks the accuracy of information and work product to provide accurate and consistent work; provides information on a timely basis and in a usable form to others who need to act on it; remains aware and takes care of details that are easy to overlook or dismiss as insignificant; compares observations of finished work to what is expected to find inconsistencies.

Escalation Process Adherence: Understands the scope of his/her decision-making authority; sorts through the facts and personal knowledge level to determine if an issue can be managed effectively or if it needs to be elevated to someone with additional knowledge that would impact the outcome; does not much let time lapse prior to making the decision to let others know; clearly and concisely explains the issue to senior leadership; ensures handoff to the next level has occurred.

Priority Setting: Spends his/her time and the time of others on what's important; quickly zeros in on the critical few and puts the trivial many aside; can quickly sense what will help or hinder accomplishing a goal; eliminates roadblocks; creates focus.

Process Management: Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient work flow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others can't; can simplify complex processes; gets more out of fewer resources.

Time Management: Uses his/her time effectively and efficiently; values time; concentrates his/her efforts on the more important priorities; gets more dome in less time than others; can attend to a broader range of activities.

Physical/visual activities or demands that are commonly associated with the performance of the functions of this job:

• Traditional office environment, with frequent visits to other areas of the facility, including production areas, loading docks, and laboratories.

• Handling of pharmaceutical product (packaged/bulk).

• Finger dexterity required to operate computer keyboard.

• Hearing at a level to enable one to hear normal conversation.

• Visual requirements of having the ability to read the computer screen, documents.

• Must wear safety glasses and other protective items as required.

• Sitting 75% of the day; standing or walking 25%

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