About this role
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 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
#ReviveRx
Why Join ReviveRX?
The best work happens when purpose meets opportunity. At ReviveRX, you'll work with a passionate, driven team that's redefining what pharmacy can be — with the resources, leadership, and culture to back it up. We offer competitive compensation, strong benefits, and real room to grow, lead, and make your mark.
Equal Employment Opportunity (EEO) and Affirmative Action Commitment
ReviveRX is committed to providing equal employment opportunities and render affirmative action to all employees and applicants for employment, including individuals who are members of underrepresented groups, without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or any other status protected by applicable federal, state, or local laws.
Reasonable Accommodations Statement
To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodation may be made to help enable qualified individuals with disabilities to perform the essential functions.
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
#ReviveRx
Why Join ReviveRX?
The best work happens when purpose meets opportunity. At ReviveRX, you'll work with a passionate, driven team that's redefining what pharmacy can be — with the resources, leadership, and culture to back it up. We offer competitive compensation, strong benefits, and real room to grow, lead, and make your mark.
Equal Employment Opportunity (EEO) and Affirmative Action Commitment
ReviveRX is committed to providing equal employment opportunities and render affirmative action to all employees and applicants for employment, including individuals who are members of underrepresented groups, without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or any other status protected by applicable federal, state, or local laws.
Reasonable Accommodations Statement
To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodation may be made to help enable qualified individuals with disabilities to perform the essential functions.
About ReviveRX
ReviveRX is hiring for the vp of quality role. NewJob aggregates active openings directly from ReviveRX's applicant tracking system, so this listing is current.
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