Compliance Manager

1 month ago

Seminole, United States HR Soul Consulting Full time

Here at HR Soul our solutions amplify the performance of people and the soul of company culture. From strategic planning with CEOs, partnering with HR leaders on key projects, building high performing teams to coaching and recruiting the future of our client’s organization.


We are currently searching for a Compliance Manager for a growing Florida-based company that works in the pharmaceutical industry.


The Compliance Manager at our client plays a pivotal role in managing the day-to-day operations of the Controlled Substance Department (CII-CV) within a pharmaceutical facility. This position ensures strict adherence to DEA regulations and state laws regarding the storage, handling, distribution, and reporting of controlled substances.


In addition to leading the team, the manager provides essential guidance during regulatory audits and inspections, safeguarding the integrity of the controlled substances inventory. The role is crucial in upholding compliance with DEA standards, implementing Standard Operating Procedures (SOPs), and ensuring the facility meets all regulatory requirements.


The ideal candidate will demonstrate exceptional leadership and organizational abilities, working closely with departments such as Operations, Quality Assurance, and HR to mitigate risks and ensure comprehensive compliance with controlled substance regulations.


Job Duties

  • Ensure adherence to DEA regulations and applicable state laws regarding the handling, storage, distribution, and disposal of controlled substances
  • Supervise the preparation and timely submission of required DEA reports
  • Stay updated on regulatory changes, making necessary adjustments to internal processes and policies to maintain compliance.
  • Act as the primary liaison during client and regulatory audits and inspections, ensuring the department remains audit-ready at all times.
  • Oversee the controlled substances inventory, ensuring accurate tracking, storage, and timely resolution of any discrepancies.
  • Maintain all required documentation, including records for shipping, receiving, destruction, and ARCOS filings.
  • Conduct routine internal audits and biennial reporting to ensure compliance with DEA standards and inventory accuracy.
  • Implement and monitor security protocols to prevent unauthorized access or diversion of controlled substances.
  • Investigate and report any incidents of theft, loss, or misuse of controlled substances to the appropriate authorities.
  • Collaborate with the Quality Assurance team to develop corrective action plans addressing any compliance gaps or security breaches.
  • Manage and mentor the team members
  • Ensure all facility registrations, permits, and state licenses are current and compliant with regulatory requirements.


Experience and Education

  • Bachelor’s degree in science or a related field (preferred)
  • 5+ years of experience in regulatory compliance and handling of controlled substances, including experience in a pharmaceutical, distribution, or reverse distribution facility.
  • 4+ years of people management experience
  • Knowledge of DEA regulations (21 CFR Part 1300) and familiarity with state pharmacy regulations.
  • Experience with change control systems, compliance audits, and state and federal regulatory reporting.
  • Demonstrated leadership and supervisory abilities, with a proven track record of coaching and mentoring teams.
  • Exceptional organizational skills, with keen attention to detail and the ability to manage multiple tasks in a fast-paced setting.
  • Proficient in Microsoft Office (Word, Excel, PowerPoint) and experienced with inventory management software.
  • Strong verbal and written communication skills, capable of effectively collaborating with various departments and regulatory agencies.
  • Excellent problem-solving and analytical abilities, able to identify risks and implement corrective measures.


At HR Soul we celebrate an inclusive environment and provide equal opportunity for development and advancement. As an equal opportunity employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, genetic information, marital status, amnesty, status as a covered veteran or uniform service member, or any other protected characteristic under applicable federal, state and/or local law.

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