Curia Manager of DEA Compliance in Burlington, Massachusetts
Manager, DEA Compliance
Curia, 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, Curia’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 Curia 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 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.
Essential Job Duties
Responsible for the controlled substance/regulated chemicals program including oversight, subject matter guidance, decision making and execution.
Partner with site leadership, clients and regulatory agencies
Provide segment and cross functional leadership regarding controlled substances and regulated chemicals
Complete comprehensive review/report of incidents, internal/external audit reports and follow-up on findings, execute remediation efforts, inform leadership and provide updates. Develop and maintain all documentation.
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 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 and maintain renewals for all Federal DEA Registrations and State Licensure and permits
Complete biannual and yearend inventories for controlled substances as required
Complete Quarterly and Year end ARCOS reporting to the DEA and required state reporting
Participate in the year end physical inventory count and compiles reconciled data for electronic submission to DEA YEI
Develop and deliver training to employees
Responsible for investigating all discrepancies in weighing’s and inventories of controlled substances/regulated chemicals
Manage and maintain all filings for state and federal DEA licenses, permits and Power of Attorney assignments
Education, Experience, Certification and Licensures
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).
Understanding of the obligations imposed upon all DEA registrants to compliment the basic requirements of FDA Current Good Manufacturing Practices (CGMPs)
Knowledge, Skills and Abilities
• Keen awareness and technical knowledge of 21 CFR Part 1300-to-end
• Strong organizational, writing, interpersonal and communication skills.
• Incumbent should expect to encounter complex interactions which include:o Routinely sought out for DEA technical expertise across departments o Active member of the Curia DEA Compliance and Management team o Routinely interacts with personnel to positively impact project goals as related to controlled substances and Regulated Chemicals
• Ability to train personnel and apply competency assessments
• Ability to interpret a variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
• Demonstrated computer capability, specifically in Microsoft Office (i.e. Word, Excel, and PowerPoint)
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel as classified. Management reserves the right to revise or amend duties at any time. Curia is an Equal Opportunity Employer.
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