Manager Of Quality And Regulatory Affairs - 503a Pharmacy

Orderly Wellness LLC

Riverview, FL, United States
Base: not specified; bonus/equity: not specified; ...
On-site
Quality management system ownership
Regulatory compliance with fda and state boards
State board and fda inspection leadership
Orderly Wellness LLC is seeking a Manager of Quality and Regulatory Affairs for their 503A compounding pharmacy in Riverview, FL. The ideal candidate will oversee compliance and quality functions, ensuring adherence to regulations while fostering a collaborative team culture

Job Summary

  • Orderly Wellness is a nationwide telehealth platform providing personalized, evidence-based treatment with a focus on quality and patient-centered care.
  • The Manager of Quality & Regulatory Affairs is a senior leadership role responsible for establishing best-in-class quality and regulatory practices and leading a team in a 503A compounding pharmacy environment.
  • Orderly Wellness offers a comprehensive benefits package including medical, dental, vision coverage, 401(k) with company match, paid time off, parental leave, and professional development resources.

Matching Summary

Match Score: 85

Orderly Wellness LLC is seeking a Manager of Quality and Regulatory Affairs for their 503A compounding pharmacy in Riverview, FL. The ideal candidate will oversee compliance and quality functions, ensuring adherence to regulations while fostering a collaborative team culture.

Salary

Base: Not specified; Bonus/Equity: Not specified; Benefits: Comprehensive medical, dental, vision, 401(k) match, paid time off, parental leave

Skills & Requirements

Must-have

  • Quality Management System ownership
  • Regulatory compliance with FDA and state boards
  • State board and FDA inspection leadership
  • Aseptic processing and cleanroom operations
  • Deviation and CAPA management
  • Batch record review and release
  • Supplier qualification and COA review

Nice-to-have

  • Team leadership and development
  • Cross-functional collaboration
  • Technology and automation integration
  • Proactive regulatory guidance
  • Strong communication and presentation skills
  • Continuous improvement culture
  • Self-directed problem solving

Key Requirements

  • Graduate-level scientific degree
  • Minimum 5 years in 503A or 503B compounding or pharmaceutical manufacturing
  • Experience leading state board inspections and FDA observations
  • Deep knowledge of USP and FDA regulations for compounding pharmacies
  • Experience building or improving Quality Management Systems
  • Experience managing deviations, CAPAs, and OOS investigations

Work Rights

Not specified

Tailored Resume

Cover Letter