Manager, Controlled Substances Compliance

Job Title

Requisition

Location

Additional Locations

Job Description Summary

Job Description

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.

• 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:

• Relocation assistance will be considered for the identified candidate as needed.

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 asides; 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 workflow; 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.

• 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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