Halo Pharmaceuticals

  • Director, DEA Compliance

    Job Location US-NJ-Whippany
    Type
    Regular Full-Time
  • Overview

    This Director, DEA Compliance is responsible for implementing and enforcing the rules and regulations governing the manufacture, warehousing, processing, packaging, labeling, distribution, and reconciliation of all classes of controlled substances as stipulated by the Federal Drug Enforcement Agency, and relevant State and Regional agencies.

    Responsibilities

     

    • Complete all required periodic reports and inventories in a timely and accurate manner.
    • Ensure the site is aligned to produce and ship scheduled substances through accurate completion of all required DEA documentation such as quota applications, inventories, destruction, shipping forms, etc. 
    • Plan and implement security procedures required for operational control at all stages of manufacturing,    packaging, labeling, processing, warehousing, and distribution of Scheduled Drug Substances.
    • Recognize the importance of documentation, as it relates to control of operations.
    • Keep current on changes to DEA Schedules and policies
    • Host and anticipate the expectations during a DEA inspection of the facility.  Issue minutes, issue and track corrective and follow-up actions to DEA inspections.
    • Collaborate with clients and internal stakeholders to develop and submit quota request for development and commercial operations.
    • Conduct internal and external audits as necessary, issue reports and recommendations to advance the control and compliance of controlled substance handling.
    • To write, review, and/or approve investigation reports, manufacturing and packaging master batch records, protocols and reports, for controlled substances.
    • Prepare written Standard Operating Procedures (SOPs) which will provide for 100% control of the schedule-identified substances operation.
    • Collaborate with site engineering to assess all internal security systems and drive improvements as necessary, recommend improvements.
    • Train, mentor, and develop staff
    • Other duties as assigned.

    Qualifications

    • Understanding of the obligations imposed upon all DEA registrants to compliment the  basic requirements of FDA Current Good Manufacturing Practices (CGMPs)
    • Bachelor's Degree (four year college or university) in scientific/pharmaceutical related field
    •  8+ years of experience working in a pharmaceutical environment in the security and DEA arena

     

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed