Position Summary
The Head of Controlled Substance Compliance is responsible for establishing, implementing, and overseeing a robust compliance framework for controlled substances across all Medivant Healthcare facilities. This role ensures full adherence to DEA regulations, the Controlled Substances Act (CSA), and 21 CFR requirements.
This is a full-time leadership position, ideal for experienced compliance professionals with deep expertise in DEA-regulated environments, who can drive compliance excellence and ensure audit readiness across the organization.
Key Responsibilities
- Serve as the primary owner of all controlled substance compliance activities across the organization.
- Ensure adherence to CSA, 21 CFR 1301 & 1304, and internal compliance standards.
- Maintain continuous readiness for DEA inspections and regulatory audits.
- Oversee end-to-end controlled substance inventory lifecycle (receipt through destruction).
- Ensure real-time inventory tracking, lot-level traceability, and zero variance reconciliation.
- Establish and maintain compliant recordkeeping systems for receipts, production, distribution, and destruction.
- Ensure complete audit trails, accurate DEA documentation, and data integrity.
- Design and implement a suspicious order monitoring system, including real-time flagging and reporting mechanisms.
- Ensure compliance in customer onboarding and distribution, including license verification and DEA number validation.
- Implement and monitor DEA-compliant storage, access controls, and diversion prevention programs.
- Lead investigations related to discrepancies or potential diversion incidents.
- Oversee destruction processes, ensuring proper documentation, chain of custody, and reconciliation.
- Develop and execute internal audit programs, including routine DEA-style audits and CAPA management.
- Establish employee screening and compliance protocols for individuals handling controlled substances.
- Collaborate cross-functionally to implement system-driven compliance controls and automation.
Qualifications
Required
- 10+ years of experience in pharmaceutical compliance within a DEA-regulated environment.
- Strong expertise in Controlled Substances Act (CSA) and 21 CFR regulations.
- Proven experience managing DEA audits, inspections, and compliance programs.
- Strong analytical, documentation, and leadership skills.
- Excellent communication and cross-functional collaboration abilities.
Preferred
- Experience in sterile injectable manufacturing or 503B outsourcing facilities.
- Familiarity with compliance systems, ERP, or electronic recordkeeping tools.
- Prior experience building or leading compliance frameworks at an organizational level.
