Quality Assurance Manager
Core
Manage the Quality Management System (QMS), regulatory compliance, and security for a veterinary and livestock distribution facility.
Role type
Quality Assurance Manager (Distribution/Logistics)
Builds
Compliant distribution operations for animal health products
Domain
Life Sciences / Veterinary / Logistics
Required skills
Quality Management System (QMS) management, Good Distribution Practices (GDP), regulatory compliance (FDA, DEA, EPA, OSHA), audit management, CAPA implementation, risk management, data integrity, security program management, health & safety program management, Lean Six Sigma, trend analysis, controlled substance inventory management
Preferred skills
None stated
Technologies
Microsoft Office Suite
Responsibilities
Maintain and monitor the BU location's QMS and compliance with state/federal regulations; Act as liaison with regulatory agencies for inspections and investigations; Conduct Quality, Health & Safety, and Security assessments; Promote a culture of Quality and compliance (USP 1079, GDP, Data Integrity); Collaborate on annual Quality Objectives and Key Business Drivers; Support training on QMS components (RCA, CAPA, change control, cGMP); Utilize metrics and trend analysis to drive improvement; Manage controlled substance inventories and reporting (ARCOS, DEA Form 222); Oversee the facility's Health & Safety Program and security breach prevention.
Seniority
Mid-Senior level, hands-on IC