VP of Quality

ReviveRX is the premier licensed pharmacy specializing in health, wellness, and restorative medicine. We focus on treating the source, not just the symptoms, utilizing industry-leading technology. Collaborating with innovative pharmacists, healthcare providers, and pharmaceutical manufacturers, we provide personalized care. Our mission is to optimize treatment, revolutionize healthcare, and empower individuals to live vibrant lives. We welcome you to join us in our commitment to holistic wellness and personalized medicine.

Position Summary

The Vice President of Quality is responsible for establishing, leading, and continuously elevating the company's overall quality and regulatory compliance. This executive role holds accountability for the integrity of Revive Rx's Quality Management System (QMS), encompassing quality assurance, quality control, document and record control, complaint management, and incoming quality. The VP of Quality serves as a primary steward of patient safety and product quality, ensuring that all compounded preparations are produced, tested, and distributed in full compliance with applicable USP Standards, State and Federal laws and regulations.

This role is a highly visible executive position requiring daily interaction with C-Suite executives, cross-functional operational leaders, and the broader quality leadership team. The VP of Quality is expected to be both a strategic visionary and a hands-on leader - someone who can set the direction for where the quality organization needs to go while simultaneously driving execution and accountability across the team.

Key Responsibilities

Quality Strategy & Organizational Leadership

• Set the strategic vision, direction, and roadmap for Revive Rx's entire quality organization - encompassing Quality Assurance, Quality Control, Document/Record Control, Incoming Quality, and Complaint Management functions
• Serve as one of the most senior quality voices within the organization, advising the CQO and other C-Suite executives on quality risk, compliance posture, and quality strategy, and overall strategic quality investment priorities
• Build, lead, mentor, and develop a high-performing quality leadership team, leading and overseeing a team of quality assurance and quality control professionals
• Partner with operational leadership and executive leadership to foster and institutionalize a self-sustaining quality culture throughout the organization
• Drive the evolution of Revive Rx's quality organization from its current state to a best-in-class compounding quality function capable of supporting significant operational scale
• Establish and oversee enterprise-wide quality governance structures including quality councils, management review programs, escalation pathways, and stage-gate processes

Quality Management System (QMS) Ownership

• Own and be accountable for the design, implementation, maintenance, and continual improvement of Revive Rx's Quality Management System
• Ensure the QMS is fully compliant with all applicable USP Standards
• Provide executive oversight of all core QMS elements: CAPA management, deviation and nonconformance management, change control, document and record control, complaint management, incoming quality, batch record review, and supplier quality
• Ensure adequate escalation pathways, management review cadences, and quality metrics/KPIs are in place to provide real-time visibility into quality system health
• Drive the selection, implementation, and optimization of electronic Quality Management System (eQMS) platforms to support operational scale and inspection readiness
• Oversee the effectiveness of implemented CAPAs and quality improvement initiatives through robust follow-up and trending mechanisms

Regulatory Compliance & Inspection Leadership

• Serve as Revive Rx's senior representative during FDA, state board of pharmacy, and other regulatory inspections
• Collaborate closely with Regulatory Affairs personnel to ensure the Quality Unit stays apprised of, acts upon and implements (i.e., ensures compliance and quality) with all applicable state licensure requirements
• Works closely with the CQO and other C-Suite executives on any/all communications with the FDA, and other regulatory bodies
• Assists, as needed, the Regulatory Affairs function, with quality related matters with any/all Form FDA 483 observations, Warning Letter, and state board deficiency citations
• Lead the development and execution of comprehensive remediation and quality improvement plans in response to audit observations, Warning Letters, 483s, or internally identified gaps

Nonconformance, Investigations, and Change Management Oversight

• Provide strategic leadership and executive oversight for nonconformances, associated investigations, root cause analysis, risk assessments and other associated problem management processes and tools across the organization
• Ensure all CAPAs, investigations, nonconformances, and remediatory actions are recorded, tracked, completed, and verified for effectiveness within…