Head of Quality and Compliance
The Pharmacy Hub•Miami Gardens, FL
•$148,000 - $182,000•Onsite
About The Position
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.
Requirements
- 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 <795>, USP <797>, USP <800>, cGMP principles, State Board of Pharmacy regulations, and DEA compliance
- Demonstrated experience leading regulatory inspections and developing quality systems from the ground up
Nice To Haves
- 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
Responsibilities
- 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 <795>, USP <797>, and USP <800>, 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
- 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
- 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
- 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
- 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
Benefits
- 401(k) with up to 4% matching
- Medical, dental, vision and life insurance
- Paid time off
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What This Job Offers
Job Type
Full-time
Career Level
Senior
