SmartPharmaRx is a 503A compounding pharmacy focused on quality and patient-centered care with a collaborative and high-standard work environment
Job Summary
SmartPharmaRx is a 503A compounding pharmacy focused on quality and patient-centered care with a collaborative and high-standard work environment.
The Director of Quality & Regulatory Affairs leads all quality and regulatory functions, ensuring compliance and readiness for inspections while building a best-in-class quality team.
Orderly Wellness offers a comprehensive benefits package including medical, dental, vision, 401(k) with match, paid time off, parental leave, and professional development resources.
Matching Summary
SmartPharmaRx is a 503A compounding pharmacy focused on quality and patient-centered care with a collaborative and high-standard work environment.
Skills & Requirements
Must-have
Quality Management System ownership
Regulatory compliance leadership
FDA and state board inspection management
Aseptic processing and cleanroom oversight
Deviation and CAPA management
Batch record review and release
Environmental monitoring programs
Nice-to-have
Collaborative team leadership
Proactive problem solving
Technology and automation integration
Cross-functional partnership
Continuous improvement culture
Effective communication skills
Key Requirements
Graduate-level scientific degree
Minimum 5 years in 503A or 503B compounding or pharmaceutical manufacturing
Experience with FDA and state board inspections
Deep knowledge of USP and FDA compounding regulations
Proven Quality Management System development
Experience managing deviations, CAPAs, and OOS investigations
Regulatory writing and executive presentation skills