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Senior Manager, DEA at Amneal Pharmceutical LLC

Posted in Management 30+ days ago.

This job brought to you by eQuest

Type: Full-Time
Location: Piscataway, New Jersey





Job Description:

Description:
 

The Senior Manager, DEA Compliance is the subject matter expert for all DEA Controlled substance matters. This role oversees the controlled substances compliance programs, as they relate to DEA and in support of the Good Manufacturing Practices.


 
Essential Functions:


  • Overall Compliance responsibilities for all assigned sites with the U.S. Drug Enforcement Administration (DEA), specifically Title 21 CFR, Part 1300 to end and applicable State, pursuant to Title 24, Section 21 to end. Works closely with regulatory licensing to ensure that all sites have required Department of Health registrations and for pharmaceutical drug products, control and no-controlled distribution in all states are in place.  Manages the DEA Export/Import program (Declarations and Permits).

  • Handles the periodic internal audits for all assigned registered facilities to ensure DEA readiness during a DEA regulatory inspections.

  • Oversee the reconciliation of all drug biennial inventories for each DEA manufacturing registrations to ensure accuracy of the year-end reports (Y-E-R-S).

  • Work with cross functions: Scientist, Engineers, Manufacturing, R&D, Facility and Analytical laboratories to ensure continues productivity of current new products. Design, develop, and implement a DEA compliance training material and program for employees.

  • Responsible for the overall security of the controlled material in vaults, cages, safes, employee authorization access to controlled substances, background check issues, security system equipment installation and modifications for all registered locations. Establish protocols for good record keeping practices. Manger department annual expenses and budgets.

  • Provides daily management of the DEA related compliance issues for all registrations; review and approve existing DEA SOPs as needed.

  • Lead or participate in missing or stolen controlled product investigation and contact DEA when appropriate.

  • Responsible for developing and maintaining the "Know Your Customer" and Suspicious Order Monitoring (SOM) policy pursuant to 21CFR 1307.74(a) and (b).

  • Be the primary site contact for the DEA inspections and all DEA correspondence.

  • Review and approve all DEA reports: monthly executed DEA Form-222s, quarterly and annual ARCOS reports, Y-E-R-S year-end reports, Import/Export permits prior to agency submittal. Review and approve the submittal of all manufacturing procurement quota applications (DEA Form 250) and supporting documentation to the DEA Quota Unit.

  • Review and approve all DEA and BI reports. Annual DEA registration renewals and apply for registrations as needed.

Education:



  • A Bachelor’s Degree (BA/BS) in a Science related field is required.
 
Experience:


  • It is required to have 5-8 years of direct experience conducting DEA compliance audits.  At least 2 years prior managerial experience.
 
Skills and Abilities:


  • Excellent communication skills, administrative skills, medium computer skills with knowledge with software e.g. word, and excel.  – Intermediate

  • Must be familiar with current DEA requirements and quota applications. – Advanced

  • Highly proficient in reviewing suspicious ordering, monitoring program (SOMP). – Advanced
 
Specialized Knowledge:


  • Title 21 US CFR and CSA