Head of Quality and Compliance

About the role

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. Quality Leadership 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 Regulatory Compliance 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 Inspection Readiness Program 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 Quality Systems Development Build and maintain comprehensive quality systems including: 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 Quality Assurance 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 Quality Control Build and manage QC laboratories and establish testing programs Oversee identity testing, potency testing, microbiology, stability, water quality, and environmental monitoring Manage incoming material qualification Internal Audit Program 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 Supplier & Vendor Quality Qualify suppliers and vendors; conduct risk assessments and vendor audits Oversee quality agreements Training & Development Develop a comprehensive quality training program for pharmacists, technicians, quality personnel, and operations teams Ensure competency assessments are completed and documented Continuous Improvement & Team Building 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

Requirements

• Required
• 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
• Preferred
• 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
• Schedule
• 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 needs
• Pay Range
• $148,000 - $182,000 USD

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