Head of Quality and Compliance

About Us

At The Pharmacy Hub
, we collaborate with pharmaceutical brands, manufacturers, health brands, telemedicine providers, and healthcare companies to deliver essential products directly to patients
. Our expertise allows us to seamlessly distribute pharmaceuticals, medical devices, and other healthcare products to consumers, ensuring greater accessibility and convenience.

The Head of Quality & Compliance is a senior leadership position responsible for building and leading a world‑class quality organization from the ground up. This role partners across Operations, Production, R&D, Procurement, Engineering, and Executive Leadership to establish a culture of quality, compliance, and continuous improvement across The Pharmacy Hub's compounding and fulfillment operations.

• Serve as the senior quality leader for all quality‑related functions
• Develop and execute the organization's quality strategy and roadmap
• Establish a culture of quality, accountability, compliance, and continuous improvement
• Partner with Operations, Production, R&D, Procurement, Engineering, and Executive Leadership

Ensure and maintain ongoing compliance with all applicable regulations and standards, including:

• USP , USP , and USP
• State Board of Pharmacy and DEA regulations
• FDA guidance documents and DSCSA requirements
• NABP requirements, OSHA regulations, and Hazardous Drug handling requirements
• Maintain inspection readiness at all times

• Develop and lead a formal Inspection Readiness Program with mock inspections
• Lead regulatory inspections and manage corrective and preventive actions (CAPAs)
• Coordinate responses to State Boards of Pharmacy, NABP, DEA, FDA, and client audits

• CAPA, Deviation, Change Control, Risk Management, and Complaint Programs
• Supplier Qualification, Training, and Annual Product Review Programs
• Internal Audit, Quality Metrics, Document Control, and Batch Record Review Programs

• Oversee batch record review and release
• Manage SOP lifecycle and governance
• Approve investigations and CAPAs
• Monitor quality trends and KPIs
• Review environmental monitoring and facility performance
• Lead product quality reviews

liBuild and manage QC laboratories and establish testing programs
• Oversee identity testing, potency testing, microbiology, stability, water quality, and environmental monitoring
• Manage incoming material qualification

• Build an internal auditing team and develop annual audit schedules
• Conduct facility, process, documentation, vendor, and client audits
• Proactively identify compliance gaps before regulatory agencies do

• Qualify suppliers and vendors; conduct risk assessments and vendor audits
• Oversee quality agreements

• Develop a comprehensive quality training program for pharmacists, technicians, quality personnel, and operations teams
• Ensure competency assessments are completed and documented

• Apply Lean, Six Sigma, and risk‑based quality principles to reduce deviations, errors, rework, waste, and complaints
• Build and lead Quality Assurance, Quality Control, Internal Audit, Compliance, Document Control, Validation, and Training teams

• Bachelor's Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, Engineering, or related field
• Minimum 10+ years of pharmaceutical quality leadership experience
• Minimum 5+ years leading quality teams
• Strong knowledge of USP , USP , USP , cGMP principles, State Board of Pharmacy regulations, and DEA compliance
• Demonstrated experience leading regulatory inspections and developing quality systems from the ground up

• PharmD, MS, or MBA
• Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE)
• Lean Six Sigma certification
• Experience in 503A Compounding, 503B Outsourcing Facilities, Pharmaceutical Manufacturing, or High‑Volume Fulfillment Operations

• Full‑time, 100% onsite position
• Work location:
  
  Davie, FL and Miami Gardens, FL (travel between locations as business needs require)
• Monday–Friday
• Occasional weekend work may be required based on business…