Director of Sterile Compounding & Quality Systems

The-Pharmacy-Hub

Miami Gardens (FL)

On-site

USD 185,000 - 225,000

Full time

16 hours ago
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Benefits offered by this job

Medical, dental, vision coverage
401(k) with 100% match up to 4%
7 holidays + PTO with rollover
Increased PTO yearly

Job summary

The Pharmacy Hub is building a modern sterile compounding operation in Florida and seeks a pharmacist leader to build, run, and continuously improve the program from the ground up. You will lead a multidisciplinary team across operations, quality, compliance, and engineering to scale sterile production, ensure regulatory compliance, and drive continuous improvement.

Ideal candidates have 10+ years in sterile compounding and a track record of implementing quality systems, training, and scalable

Qualifications

  • Experience building or expanding a sterile compounding program.
  • Extensive knowledge of USP <797> and USP <800>.
  • Strong quality-system, cleanroom, and regulatory-inspection experience.

Responsibilities

  • Lead the sterile compounding program buildout from design to operational readiness and scale.
  • Mentor and lead a high-performing team of pharmacists, technicians, and quality staff.
  • Ensure USP <797>/<800> compliance and translate regulations into workflows for frontline staff.
  • Develop and oversee the pharmaceutical quality system (deviations, CAPA, change control, investigations).
  • Partner with facilities, engineering, and compliance on cleanroom design and qualification.
  • Design sterile production workflows, establish KPIs and dashboards for production metrics.
  • Collaborate on formulation development for injectable and sterile formulations.
  • Build sterile training programs and competency assessments for ongoing staff development.
  • Maintain inspection readiness for Board of Pharmacy, FDA, and accreditation.
  • Integrate sterile workflows into ERP and quality dashboards.

Skills

Sterile compounding program
USP <797> & USP <800>
Quality systems
Regulatory inspections
Pharmacist team management
Aseptic processing

Education

PharmD or BS in Pharmacy

Job description

The Pharmacy Hub is building a modern sterile compounding operation in Florida and seeks a pharmacist leader to build, run, and continuously improve the program from the ground up. You will lead a multidisciplinary team across operations, quality, compliance, and engineering to scale sterile production, ensure regulatory compliance, and drive continuous improvement.

Ideal candidates have 10+ years in sterile compounding and a track record of implementing quality systems, training, and scalable

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