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 ComplianceEnsure 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 DevelopmentBuild 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
QualificationsRequired- 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
Benefits:- 401(k) with up to 4% matching
- Medical, dental, vision and life insurance
- Paid time off
