Compliance Manager / Director (Pharmaceutical Distribution)
The International Society for Pharmaceutical Engineering, Inc., Frankfort, Kentucky, United States
Position Overview
We are seeking a
Compliance-experienced professional , ideally with pharmaceutical distribution experience and/or a licensed
Pharmacist , to oversee and strengthen our compliance, regulatory, and quality systems as we continue to grow.
Key Responsibilities
Oversee compliance with
FDA, DEA, state Boards of Pharmacy , and wholesale distributor regulations
Maintain and manage
state and federal licenses
(including renewals, applications, and inspections)
Develop, implement, and enforce
SOPs
for receiving, storage, dispensing, recalls, returns, and quarantined inventory
Ensure compliance with
DSCSA
requirements (pedigree, tracing, verification, serialization readiness)
Manage
DEA-controlled substance compliance , including thresholds, reporting, and internal controls
Lead and prepare for
audits and inspections
(DEA, state BOP, manufacturers, trading partners)
Oversee
recall procedures , suspicious order monitoring, and compliance reporting
Train warehouse and operations staff on compliance procedures and documentation
Serve as internal compliance authority and point of contact with regulators
Preferred Qualifications
Pharmaceutical distribution compliance experience REQUIRED
Pharmacist license (RPh or PharmD) strongly preferred , but not required
Experience working with:
Wholesale drug distribution operations
DEA-scheduled drugs (C2–C5)
State Board of Pharmacy regulations
DSCSA compliance
Strong understanding of warehouse workflows, receiving, inventory controls, and documentation
Experience creating and enforcing SOPs
Highly organized, detail-oriented, and audit-ready mindset
What We’re Looking For
Someone who can
build systems , not just check boxes
Comfortable pushing back when something isn’t compliant
Practical, business-minded compliance professional
Confident communicator with regulators and internal teams
Compensation & Benefits
Competitive salary (commensurate with experience)
Potential for senior-level title depending on qualifications
Growth opportunity with an expanding distributor
Direct access to leadership and decision-making
#J-18808-Ljbffr
Compliance-experienced professional , ideally with pharmaceutical distribution experience and/or a licensed
Pharmacist , to oversee and strengthen our compliance, regulatory, and quality systems as we continue to grow.
Key Responsibilities
Oversee compliance with
FDA, DEA, state Boards of Pharmacy , and wholesale distributor regulations
Maintain and manage
state and federal licenses
(including renewals, applications, and inspections)
Develop, implement, and enforce
SOPs
for receiving, storage, dispensing, recalls, returns, and quarantined inventory
Ensure compliance with
DSCSA
requirements (pedigree, tracing, verification, serialization readiness)
Manage
DEA-controlled substance compliance , including thresholds, reporting, and internal controls
Lead and prepare for
audits and inspections
(DEA, state BOP, manufacturers, trading partners)
Oversee
recall procedures , suspicious order monitoring, and compliance reporting
Train warehouse and operations staff on compliance procedures and documentation
Serve as internal compliance authority and point of contact with regulators
Preferred Qualifications
Pharmaceutical distribution compliance experience REQUIRED
Pharmacist license (RPh or PharmD) strongly preferred , but not required
Experience working with:
Wholesale drug distribution operations
DEA-scheduled drugs (C2–C5)
State Board of Pharmacy regulations
DSCSA compliance
Strong understanding of warehouse workflows, receiving, inventory controls, and documentation
Experience creating and enforcing SOPs
Highly organized, detail-oriented, and audit-ready mindset
What We’re Looking For
Someone who can
build systems , not just check boxes
Comfortable pushing back when something isn’t compliant
Practical, business-minded compliance professional
Confident communicator with regulators and internal teams
Compensation & Benefits
Competitive salary (commensurate with experience)
Potential for senior-level title depending on qualifications
Growth opportunity with an expanding distributor
Direct access to leadership and decision-making
#J-18808-Ljbffr