Director of Compliance
Emerald Compounding Pharmacy - Tampa, FL
Hiring: Director of Compliance Company: Emerald Compounding Pharmacy Location: Tampa, FL Job Posted Time: 2026-09-12 12:08:42 Target Skills & Keywords : HIPAA About the job Experience: •7+ years of progressive compliance, regulatory affairs, or quality experience in pharmacy, pharmaceutical manufacturing, or a related healthcare setting, with at least 3 years leading a compliance function or major program. •At least 3 years leading a compliance function or major program. Required Skills: •Own the compliance program. I mplement and continuously improve Emerald’s enterprise compliance program covering pharmacy practice, sterile and non-sterile compounding, privacy, and commercial conduct. •Serve as primary point of contact for state boards of pharmacy, FDA, DEA, and accreditation bodies. Manage the multi-state licensure portfolio (resident and non-resident permits, renewals, change notifications, NABP/VPP programs) and expand it as the business enters new states. •Lead preparation for and response to state board, FDA, DEA, and accreditation inspections, including mock inspections, 483/observation responses, and corrective and preventive action (CAPA) plans. •Partner with the Pharmacist-in-Charge and Quality to ensure operations meet USP <795>, <797>, and <800> standards and applicable 503A requirements, including bulk drug substance sourcing, beyond-use dating, environmental monitoring, and documentation. •Maintain the complete SOP library; build and deliver role-based compliance training and competency assessments for all staff; track completion and effectiveness. •Kickback considerations, marketing and advertising claims, and partner due diligence and audits. •Oversee DEA registration, recordkeeping, inventory reconciliation, and suspicious-order monitoring.• Qualifications: •PharmD or RPh with an active license in the State of Florida •Direct experience with compounding pharmacy regulation: state boards of pharmacy, FDA 503A requirements (503B experience a plus), USP <795>/<797>/<800>, and DEA controlled-substance rules. •Track record managing multi-state pharmacy licensure and successfully navigating regulatory inspections. •Kickback, Stark), and FTC/state advertising rules as they apply to healthcare. •Demonstrated capacity to translate regulation into practical operating procedures and to win buy-in from clinical, operations, and commercial teams. •Excellent written communication: you can draft a clear SOP, a persuasive inspection response, and a crisp board update. •Calm, decisive judgment under pressure and unimpeachable integrity. •Preferred:CHC, CCEP, or similar compliance certification; PCAB/ACHC accreditation experience; experience in a high-growth or private-equity-backed healthcare company. •A leadership role with real authority to shape how the company operates, working directly with the Chief Compliance Officer and executive team. •A business at an inflection point in a category (compounded therapies and telehealth) where compliance excellence is the moat. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!