Director of Controlled Substance Compliance

Tailstorm Health Inc•Chandler, AZ

About The Position

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.

Requirements

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.

Nice To Haves

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.

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.