Manager DEA Compliance

6/3/21

Albuquerque, NM 87101

1254

FullTimeRegular

Manager, DEA Compliance

The Manager, DEA Compliance is a member of the DEA Compliance team reporting to the Director of DEA Compliance in close partnership with the site leadership team, as well as clients and regulatory agencies. This role provides oversight and subject matter guidance for controlled substances and regulated chemicals to ensure compliance with all regulatory requirements. The Manager, DEA Compliance is responsible for leadership, administration and harmonization of the controlled substance/regulated chemicals program including development and implementation of corporate and plant policies, applicable standards, best practices, procedures and processes, while ensuring continuous improvement of the program.

The Manager, DEA Compliance has responsibility for the controlled substance/regulated chemicals program throughout all segments and cross functionally and ultimately accountable for all capabilities being in place down to execution. The Manager, DEA Compliance must have the ability to lead and influence peers and cross functional teams.

Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.

Key Responsibilities:

  • Responsible for the controlled substance/regulated chemicals program including oversight, subject matter guidance, decision making and execution.
  • Partnering with site leadership, clients and regulatory agencies.
  • Provide segment and cross functional leadership regarding controlled substances and regulated chemicals.
  • Provide subject matter guidance both internal and external, support and execute strategic decisions while ensuring all controlled substance policies and procedures meet or exceed regulatory standards, expectations and requirements.
  • Complete comprehensive review/report of incidents, internal/external audit reports and follow-up on findings, execute remediation efforts, inform leadership and provide updates.
  • Monitor the performance of the controlled substance/regulated chemicals program and related activities. Initiate dialogue with appropriate stakeholders, spearhead applicable steps to improve the program’s effectiveness.
  • Responsible to manage and limit risk exposure.

Other Duties:

  • Develop and maintain all documents required to submit and track quota applications to the Drug Enforcement Agency for the site.
  • Ensure access to all controlled substance storage locations adhere to organizational requirements.
  • Prepare and maintain all documentation to support site audits by the Drug Enforcement Agency (DEA). Maintain audit readiness documentation.
  • Responsible for maintaining accurate and updated inventories for all controlled substances.
  • Perform internal audits as it relates to DEA/State Investigations, Inventory Accountability, documentation, compliance with 21 CFR 1301.71-1301.76.
  • Manage the filing, execution, review, ordering and dispensation of DEA Form 222 for the site. This includes 222 forms for the QC Laboratory, incoming/outgoing controlled substance reference standards, incoming customer 222 forms, and any incoming controlled substances.
  • Review and revise Controlled Substance Batch records for accountability and regulatory compliance.
  • Manage and maintain renewals for all Federal DEA Registrations and State Licensure and permits
  • Works with various agencies to ensure all licensing for the site is applicable, accurate, complete and current.
  • Prepare and submit Import/Export applications to DEA through IMEX. Review and close-out Declarations and Permits as required. Ensure that required copies of declarations and permits are retained and filed according to 21 CFR 1300. Complete biannual and yearend inventories for controlled substances as required.
  • Complete Quarterly and Year end ARCOS reporting to the DEA and required state reporting.
  • Performs routine site tours to verify compliance
  • Participates in the year end physical inventory count and compiles reconciled data for electronic submission to DEA YEI.
  • Coordinate all destruction for controlled substances along with the documentation required to transfer to a reverse distributor for destruction.
  • Write and revise all site SOP’s related to controlled substances.
  • Develop and deliver training to employees
  • Responsible for investigating all discrepancies in weighing’s and inventories of controlled substances/regulated chemicals.
  • Participate in customer and DEA Audits.
  • Participate in self-development activities.
  • Communicate quota requirements with Supply Chain to drive the production schedule.
  • Manage and maintain all filings for state and federal DEA licenses and permits.
  • Manage Power of Attorney assignments.
  • Perform other related duties as may be reasonably assigned in the course of business.

Supervisory Responsibilities:

  • No direct reports.

Education and/or Experience:

  • BS and/or 3 - 7 years’ experience in pharmaceutical DEA Compliance.
  • Keen awareness and technical knowledge of 21CFR Part 1300-to-end.
  • Experience in pharmaceutical procedure implementation, Good Manufacturing and Laboratory Practices and current compliance standards (e.g., Good Documentation Practices).
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