AMRI DEA Compliance Manager (Remote) in ALBANY, New York
Title: DEA Compliance Manager (Remote)
Other Locations: US-Massachusetts, US-Wisconsin, US-New Jersey
Job Number: 1004074
DEA Compliance Manager
AMRI, a global contract research and manufacturing organization, partners with the pharmaceutical and biotechnology industries to improve patient outcomes and quality of life. With locations in North America, Europe and Asia, AMRI’s team combines scientific expertise and market-leading technology to provide a complete suite of solutions in Discovery, Development, Analytical Services, API Manufacturing and Drug Product.
The DEA Compliance Manager is a member of the AMRI DEA Compliance team reporting to the Director of DEA Compliance in close partnership with the site leadership teams, 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 across multiple facilities. The DEA Compliance Manager 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 at multiple facilities.
The DEA Compliance Manager 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.
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 across multiple facilities. Initiate dialogue with appropriate stakeholders, spearhead applicable steps to improve the program’s effectiveness.
Responsible to manage and limit risk exposure.
Develop and maintain all documents required to submit and track quota applications to the Drug Enforcement Agency across multiple facilities.
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 at multiple facilities.
Responsible for maintaining accurate and updated inventories for all controlled substances at multiple facilities.
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 at multiple facilities.
Review and revise Controlled Substance Batch records for accountability and regulatory compliance across multiple facilities.
Manage and maintain renewals for all Federal DEA Registrations and State Licensure and permits across multiple facilities.
Works with various agencies to ensure all licensing for the facilities are 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 Yearend ARCOS reporting to the DEA and required state reporting.
Performs routine tours of multiple facilities 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 at multiple facilities.
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 across multiple facilities.
Manage Power of Attorney assignments.
Perform other related duties as may be reasonably assigned in the course of business.
No direct reports.
Education and/or Experience:
BS with 7-10 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).
Other Skills and Abilities:
Strong organizational skills.
Strong writing skills.
Demonstrated ability to prioritize and manage documents, time, and people.
Strong interpersonal and communication skills. Incumbent should expect to encounter complex interactions which include:
Routinely sought out for DEA technical expertise across departments.
Active member of the AMRI DEA Compliance and Management team.
Routinely interacts with personnel to positively impact project goals as related to controlled substances and Regulated Chemicals.
All interested applicants must apply online. AMRI is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Other Locations: US-Massachusetts, US-Wisconsin, US-New Jersey
EOE Protected Veterans/Disability
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