QuVa Pharma

Manager, DEA Compliance

QuVa Pharma$90K — $120K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in life science or relevant field
  • 5-7 years' experience in a DEA Manufacturing regulated environment
  • 3+ years in a leadership capacity
  • Experience in maintaining DEA compliance systems
  • Knowledge of security requirements
  • Ability to lift up to 50 lbs and perform physical tasks

Responsibilities

  • Manage DEA compliance activities at multiple registration locations
  • Oversee Controlled Substance Inventory reconciliation across various lot levels
  • Implement and support YERS inventories
  • Coordinate movement of controlled substances during manufacturing processes
  • Train staff on controlled substance Standard Operating Procedures
  • Conduct and document DEA audits at facilities
  • Maintain current knowledge of DEA regulations

Benefits

  • Comprehensive health and wellness benefits including medical, dental and vision
  • 401k retirement program with company match
  • 22 paid days off plus 8 paid holidays annually
  • Opportunities for career advancement in a high-growth company
Full Job Description
Our Manager, DEA Compliance plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. Once you complete our training, your responsibilities will include managing all aspects of DEA reporting and compliance for both manufacturing and laboratory licenses at respective Quva Pharma facilities. This person will be responsible for ensuring that Quva Pharma's manufacturing operations are complying with the Drug Enforcement Administration (DEA) and maintain Quva's commitment to high quality and regulatory standards. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.

This is an onsite role located in Sugar Land, Texas.

What The Manager, DEA Compliance Does Each Day:

  • Manages and coordinate all DEA related activities at multiple DEA registration locations
  • Manages Controlled Substance Inventory, including but not limited to:
    • Raw material, material in process and finished product inventory reconciliation per each lot level
    • Organizes inventory cycle count
    • Organizes middle year, year end and biennial inventory count, and prepare report in compliance with authorities' requirement accordingly
  • Is responsible for implementing and gathering data to support YERS inventories
  • Coordinates all movement of control substances from manufacturing through analytical testing
  • Trains internal individuals on controlled substance Standard Operating Procedures
  • Coordinates all controlled substance destruction with appropriate Quality and Logistics departments
  • Coordinates and documents DEA audits for sites and issue audit reports to management upon completion
  • Remains current on DEA regulations in order to address organization business needs
  • Serves as an expert resource to site management in communicating to the authorities and troubleshooting with respect to Controlled Substances
  • Manages Controlled Substances transaction reporting to DEA, and state BOP
  • Keeps current on all State Controlled Substance Reporting requirements
  • Collaborates with site teams for process excellence programs as SME of DEA compliance
  • Collaborates with other critical compliance reports to regulatory agencies as needed, such as theft and loss
  • Maintains the DEA compliance documentation system and keep continuously improving the controlled substance management process so to ensure systems meet up to date regulation requirements
  • Leads and gathers documentations for DEA, state BOPs and customer audit


Our Most Successful Manager, DEA Compliance:

  • Has a sense of urgency, accountability and resourcefulness
  • Advances continuous improvement programs and transformation initiatives
  • Is a self-starter and independent learner
  • Promotes active listening with team members; Contributes appropriately to conversations; Strong verbal and written communication skills with the ability to work effectively with other departments within the organization and with people at all levels of the organization
  • Understands how various issues affect each other and the outcome of projects; Improves upon existing approaches by seeking opportunities to creatively transform


Minimum Requirements for this Role:

  • Bachelor's degree in life science or relevant field
  • 5 - 7 years' work experience in a DEA Manufacturing regulated environment with 3+ years in a leadership capacity
  • Experience in maintaining DEA compliance systems
  • Implementing compliance systems to maintain corporate compliance of all DEA regulations
  • Knowledge in the security requirements
  • Able and willing to walk, stoop, stand, bend, and lift up to 50 lbs. throughout each shift, with or without reasonable accommodation
  • Able to successfully complete a drug and background check
  • Must be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visas


Benefits of Working at Quva:

  • Comprehensive health and wellness benefits including medical, dental and vision
  • 401k retirement program with company match
  • A minimum of 22 paid days off plus 8 paid holidays per year
  • National, industry-leading high growth company with future career advancement opportunities


About QuVa Pharma

QuVa Pharma is a pharmaceutical company that specializes in the production and distribution of sterile injectable drugs. The company's products are used in hospitals, clinics, and other healthcare facilities to treat a variety of conditions, including pain, infections, and cancer. QuVa Pharma's facilities are located in Texas and North Carolina, and the company has distribution centers throughout the United States. The company was founded in 2015 and is headquartered in Sugar Land, Texas.
Learn more about QuVa Pharma
Size
500 employees
Industry
Founded
2015

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