The DEA Compliance Manager will manage the Controlled Substance (CS) program and support Good Manufacturing Compliance (GMP) programs to assure compliance with regulations, as well as Neos Therapeutics policies and procedures. The primary responsibility of this position is to lead various CS activities to maintain a consistent and high level of compliance to Drug Enforcement Administration (DEA) regulations. Responsibilities also include: DEA compliance initiatives, training, liaising with local and headquarter DEA Field Offices along with being the Subject Matter Expert (SME) on CS compliance. The Compliance Manager will monitor, prepare and assure compliance with 21 CFR 1300 and applicable Neos Therapeutics SOPs and DOPS. The individual will work well with senior leadership in the development and implementation of policies and procedures, which minimize the exposure to the adverse effects of pharmaceutical diversion.
Key Job Functions and Responsibilities:
• Serve as DEA liaison with local DEA office and headquarters
3. Paper communication
• Act as Subject Matter Expert (SME) on Controlled Substances and DEA regulations
• Lead DEA site audits
• Interface with the DEA and review/approve changes to company policies and procedures
• Compile and submit information from various departments to complete required DEA reports (ARCOS, opiate, import/export, biennial and year-end)
• Review and approve deviations as they relate to DEA activities
• Approve change controls and master data requests on behalf of DEA compliance
• Effectively manage and ensure appropriate DEA records, reports and 222 forms are accurately completed, processed and filed in accordance with DEA regulations
• Provide site training for DEA and controlled substance regulations and compliance
• Provide primary oversight of Controlled Substance program, practices and procedures
• Prepare gap assessment evaluations for regulatory changes and ensure mitigation plans are developed and carried out to maintain site compliance
• Perform internal audits, site walk-throughs and inspection readiness activities to verify regulatory compliance
• Track, manage, and prepare Corrective Actions/Preventive Actions (CAPAs), and audit responses
• Manage requests related to compliance, regulatory submissions, licenses and renewals
• Maintain import/export permits. Submit monthly permit information
• Provide Sales Associate compliance & training as appropriate
• Provide ongoing direction to the team and provide development opportunities as needed
• Oversee 222 management with vendors and 3PLs
• Manage anti-diversion initiatives and maintain product licensing and renewal processes.
• Responsible for Suspicious Order Monitoring for Neos and 3PLs
• Oversee Theft/Loss investigating and reporting
• Review Clinical Study reports and submissions for company and individuals involved in controlled substance “red flags”
• Assist with and participate in a variety of quality and regulatory projects as required
• Power of Attorney management
• Manage inventory quota and applicable requirements:
1. Annual submissions
2. Increase submissions
3. Maintain metrics
4. Certificate of available quota (with manager review and signature)
• Ensures polices, legislation and procedures are adhered to: including company SOPs, 21 CFR Part 11 and Sarbanes-Oxley (SOX) compliance, as appropriate to positon
• Perform other duties as required
• Must possess strong communication skills, critical thinking skills, interpersonal skills, interpretation skills and analytical skills. Must also exhibit exceptional organizational, time management and supervisory skills. This position demonstrates leadership ability by acting as an important part of the Neos Therapeutics team and mentoring junior roles within the department.
• Receive guidance with respect to general objectives; in the majority of tasks and projects assigned, determine work sequence, scheduling, and how to achieve objectives of assignments while operating within specific policy guidelines.
• Bachelor’s degree required
• Minimum 7 years relevant experience (manufacturing/cGMP/FDA industry, compliance, supply chain) with at 2 years focused within the pharmaceutical industry. Must be familiar with pharmaceutical practices, cGMP, FDA and DEA regulations, process and requirements.
• In addition, minimum of 2 years managerial/supervision experience dealing with the DEA, FDA and controlled substance compliance oversight
• Excellent problem solving skills
• Demonstrated compliance, documentation and technical writing skills
• Strong team player with excellent communication and collaborations skills
• Ability to apply advanced mathematical concepts
• Intermediate Level in Microsoft Office suite
(Microsoft Word, Excel, PowerPoint, Outlook and Access)
• Proficient in ERP systems
• Well-lit, heated and/or air-conditioned indoor office/production setting with adequate ventilation
• Moderate physical activity performing somewhat strenuous daily activities of a primarily product/technical nature
Neos is a small but growing company where each individual can make a huge difference. The company operates under strict guidelines and as such requires all potential employees to undergo a drug test prior to their start date. The company also conducts drug tests several times throughout the year.
Physical demands described in this job description are representative of those that must be met by the employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.