Head of Quality and Compliance

Job Description

Job Description

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.

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 <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

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

Qualifications

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 <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

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

• Customer-first mindset - we develop strong partnerships with telehealth platforms and healthcare companies to enhance access and understand their specific needs
• Innovation for intervention in care - we develop advanced compounding solutions and products to better support patient health outcomes
• Continuous improvement - we continuously improve our processes and offerings through intelligent, honest and transparent practices to deliver cost-effective solutions that truly benefit our clients and their patients.

At The Pharmacy Hub , we don't just offer jobs—we offer opportunities for career growth and development. We take pride in our fast-paced, team-driven culture and are committed to supporting our employees in achieving success.

If you're ready to join a company that values hard work, dedication, and teamwork, apply today! We look forward to welcoming you to The Pharmacy Hub and working together to deliver top-tier pharmacy fulfillment solutions.

The Pharmacy Hub is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law. Applicants requiring a reasonable accommodation to participate in the hiring process are encouraged to indicate this in their application.

The Pharmacy Hub participates in E-Verify. A post-offer background check is required for all positions. Additional pre-employment screenings may apply depending on the role.