Vice President of Quality

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 ReviveRx'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 ReviveRx'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 ReviveRx'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 ReviveRx'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 ReviveRx'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 committed timelines
• Hold quality and operational leadership accountable for timely closure of open quality events, aging CAPAs, and overdue investigations
• Ensure adequate trending of quality metrics/potential systemic quality issues, drive proactive potential assessment and risk
• Develop advanced processes for the efficient and accurate recording of quality incidents, setting internal standards that reflect best-in-class pharmaceutical practices

Complaint Management & Patient Safety

• Oversee ReviveRx's complaint management program, ensuring all product and service complaints are properly logged, tracked, trended, and acted upon
• Ensure the organization has robust processes for evaluating adverse events, determining appropriate regulatory reporting obligations, and escalating serious patient safety concerns
• Partner with the Complaint Coordinator and operational leadership to drive timely, thorough, and compliant resolution of all customer complaints
• Leverage complaint data as a strategic quality improvement tool — identifying patterns, informing CAPA priorities, and driving systemic process improvements

Quality Control & Laboratory Oversight

• Provide executive oversight of ReviveRx's Quality Control function, including all analytical and microbiological testing programs, environmental monitoring, stability programs, and third-party contract laboratory management
• Partner with the leadership of the QC function on laboratory startup strategy, design, and operationalization of ReviveRx's internal testing capabilities
• Ensure QC operations are inspection-ready, scientifically sound, and have integrity in all data, and utilize practices that stay compliant with all applicable USP Standards and State and Federal regulations
• Champion data integrity, ALCOA+ principles, and Good Documentation Practices (GDPs) as non-negotiable foundations of QC operations — ensuring an enterprise-wide understanding that quality is everybody's responsibility

Cross-Functional Collaboration & Operational Partnership

• Partner closely with operations, compounding, dispensing, supply chain, procurement, facilities, and regulatory affairs leadership to ensure quality is embedded across all operational processes
• Provide strategic quality guidance during new product introductions, process changes, facility expansions, and technology transfers
• Serve as a constructive but uncompromising quality partner to operational teams — maintaining quality independence while supporting operational success
• Lead change management initiatives to implement new quality systems, processes, and cultural expectations across the organization
• Serve as the back-up to the CQO in representing quality at executive leadership team meetings, board-level discussions, and external stakeholder engagements as required

Team Development & Organizational Capability Building

• Recruit, develop, and retain top quality talent across all levels of the quality organization
• Build organizational capability in quality science, regulatory knowledge, investigation techniques, and continuous improvement methodologies
• Establish mentoring and development programs to grow the next generation of quality leaders within ReviveRX
• Create a high-accountability, high-support quality culture where team members are empowered to raise issues, solve problems, and drive improvements/improved outcomes
• Define clear organizational structures, roles, responsibilities, and career pathways within the quality function

Required Qualifications

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, Life Sciences, Engineering, or related technical field
• 15+ years of progressive experience within the pharmaceutical and/or compounding industry
• Minimum 7-10 years in senior quality leadership roles with direct P&L or budget accountability
• Demonstrated experience owning regulatory inspection strategy and serving as the primary senior quality representative during FDA and/or state board inspections
• Proven track record of successfully managing regulatory observations, Warning Letters, 483s, or state board deficiencies
• Demonstrated experience building, scaling, and leading quality organizations in growth-stage or highly regulated environments
• Track record of successful senior executive-level collaboration and influence
• Deep knowledge of applicable USP Standards (USP <797>, <795>, <800>, <1163>) as well as all applicable State and Federal laws and regulations
• Comprehensive understanding of QMS design and management aligned with ICH Q10
• Expertise in CAPA systems, deviation management, complaint handling, change control, and document control
• Deep understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDPs)
• Exceptional executive leadership with the proven ability to coach, mentor, inspire, and develop quality leaders and teams at all levels
• Demonstrated ability to lead organizational change

Preferred Qualifications

• Advanced degree (MS, PhD, PharmD, MBA)
• Six Sigma certification (Green Belt or higher)
• PMP or equivalent project management certification
• Direct experience with sterile and/or non-sterile compounding, pharmaceutical manufacturing, or specialty pharmaceutical operations
• Knowledge of FDA CGMP regulations (21 CFR Parts 210/211)

Work Environment & Physical Requirements

• Primarily in a professional office setting within a regulated pharmaceutical compounding facility
• Frequent presence on the production floor and in cleanroom/controlled environments
• Fast-paced, highly regulated, and deadline-driven, requiring the ability to manage competing priorities while maintaining rigorous attention to detail
• Regular exposure to pharmaceutical compounding areas, including cleanrooms and sterile manufacturing zones, may occur
• Flexibility in working hours to accommodate regulatory inspection schedules, audit preparation activities, and executive-level business needs
• Occasional travel may be required for regulatory agency meetings, vendor audits, industry conferences, or multi-site oversight activities
• Ability to sit for extended periods while performing administrative, analytical, and computer-based tasks
• Ability to stand and walk for extended periods during floor audits, inspections, and facility walkthroughs
• Occasionally required to gown and enter cleanroom or controlled environments in accordance with applicable SOPs and USP standards
• Ability to lift and carry up to 25 pounds occasionally

Featured Benefits  

• Competitive salary
• Comprehensive health, dental, and vision insurance
• 401k with employer match
• Paid Time Off
• Employee Perks & Discounts