DEA Manager

ABOUT THE COMPANY:

Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to the core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence.

JOB LOCATION:

Nivagen Pharmaceuticals Inc., Sacramento, CA

3900 Duckhorn Dr, Sacramento, CA 95834

JOB SUMMARY:

Play a critical role in the day-to-day activities of the DEA Compliance program as it relates to Title 21 CFR, Part 1300-End and the Drug Enforcement Administration (DEA), as well as ensure compliance with all federal and state regulations. Coordination and support of all DEA and state-regulated activities for all Greenville operations. The essential duties and responsibilities listed below are representative of those required on the job. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential duties and responsibilities.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Support day-to-day tasks to maintain DEA Federal and State controlled substance compliance across multiple sites and to identify and achieve departmental strategies and objectives. Liaison for the DEA, SC-DPH, and other state and local agencies as required.
• Creation and revision of procedures to ensure correct documentation, traceability, and accountability as it relates to DEA-controlled substances and SC-DPH activities to minimize the risk of diversion.
• Preparation and submission of periodic reports to the DEA (ARCOS, CSOS, YERS, and Quota Procurement Requests, etc.).
• Coordinate and over-sight of reconciliation audits of controlled substance inventories for all DEA Registrations (Annual, Biennial, Year-End, etc.)
• Evaluate controlled substance inventory discrepancies, in-transit losses, and suspicious orders, and report findings to the DEA, SC-DHP-Bureau of Drug Control and other state BOP's, as necessary.
• Ensure all facilities and controlled substances storage locations are compliant with DEA and state regulations.
• Work with DEA Compliance, Quality management, EHS, and Security to ensure all facilities and controlled substance storage areas are compliant with DEA and state regulations.
• Lead Regulatory Inspections by DEA and SC-DHP. Participate in other Regulatory Inspections (FDA) as required to support. Participate in customer audits.
• Coordination of the Controlled substance destruction process, both internal and external. Maintain an understanding of and abide by all cGMPs, compliance, regulatory, and quality requirements.
• Filing and auditing of all DEA Compliance documentation.
• Conduct internal and external DEA compliance due diligence reviews for potential acquisitions or newly acquired companies.
• Coordinates with the Chief Quality Officer to ensure compliance issues are addressed in a timely manner.
• Assist in the recruitment, training, and onboarding of new employees.
• Coordinate training and professional development activities for employees.
• Conduct staff performance reviews.
• Maintain and adhere to departmental budget, as required.
• Perform other related duties as required or assigned.
  
  

EDUCATION AND/OR EXPERIENCE:

Bachelor's degree in a scientific field. 10 years of related work experience in the pharmaceutical industry, with an emphasis on regulatory reporting preferred, specifically DEA experience. This position manages the DEA Compliance department(s) and personnel.

KNOWLEDGE, SKILLS & ABILITIES:

Previous work experience in the pharmaceutical industry with an emphasis on DEA compliance, or relevant experience in a related field. Knowledge of and ability to apply cGMP and DEA regulations as they relate to liquid pharmaceutical manufacturing. Demonstrate people skills to develop and maintain strong working relationships in a multi-disciplinary environment. Strong oral and written communication skills. Advanced organizational skills. Detail-oriented. Microsoft Suite software is required. Ability to function well in a high-paced and at times stressful environment.

PHYSICAL REQUIREMENTS/WORKING CONDITIONS:

The physical requirements and working conditions listed for this job are representative of those required on the job. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential duties and responsibilities. Typical office environment requiring the use of typical office equipment (e.g., computers, phones, etc.). Computer keyboarding, computer monitor, and mouse, including reaching forward, grasping, finger and wrist manipulations, and neck bending and turning; near vision is necessary for computer monitor use.

Continuously required to stand, sit, walk, talk, and hear, frequently required to stand, sit, walk, talk, and hear, occasionally required to reach with hands and arms, climb or balance, stoop, kneel, crouch, or crawl. Frequently lift to 30 lbs. While performing the functions of the job, the employee is occasionally exposed to work near moving parts, fumes, or airborne particles, toxic or caustic chemicals, or outdoor weather conditions of extreme heat or cold.

BENEFITS:

• Pay range $100,000-$140,000 per year
• Performance-Based Incentive
• Benefits: Medical, Dental, and Vision coverage
• Paid time off plan
• 401 (k) savings plan
  
  

To perform this job successfully, an individual must be able to perform the essential job functions satisfactorily. Nivagen Pharmaceuticals is an Equal Opportunity Employer. In compliance with the Americans with Disabilities Act, Nivagen will provide reasonable accommodations to qualified individuals with disabilities and encourages both prospective and current employees to discuss potential accommodations with the employer. Nivagen uses E-Verify.

This job description is not a contract, and the duties/expectations and requirements may change.