VP of Quality - Pharmaceutical / Compounding position at ReviveRX Pharmacy, LLC.| United States Of America

ReviveRX Pharmacy, LLC VP of Quality - Pharmaceutical / Compounding

Experience: 15 Years

Pattern: On-site

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Bachelor's (B.Sc.)

Houston, TX....United States Of America

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. VP of QualityRevive RX Houston, TX (On-site Executive Role)Position OverviewThe Vice President of Quality, reporting to the Chief Quality Officer, is the second most senior quality leader at ReviveRX, 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. The ideal candidate brings 15+ years of progressive pharmaceutical and/or compounding industry experience, with a demonstrated track record of building world-class quality organizations, successfully navigating regulatory inspections, and leading culture change toward sustainable quality excellence.Key ResponsibilitiesQuality 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 — one that goes beyond compliance, audits, and crisis response toward genuine quality excellence embedded in every operational decision•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•Champion quality as an enterprise responsibility — not a QA-only function — by partnering with operational leaders to embed quality thinking into organizational behavior, decision making, and execution•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 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 (USP <797> Pharmaceutical Compounding – Sterile Preparations, USP <795> Pharmaceutical Compounding – Non-Sterile Preparations, USP <800> Hazardous Drugs, USP <1163> Quality Assurance in Pharmaceutical Compounding), as well as all applicable State and Federal laws and regulations•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 — owning the inspection strategy, preparation, and response•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, thereby ensuring organizational compliance through ReviveRX's Quality Management System•Works closely with the CQO and other C-Suite executives on any/all communications with the FDA, and other regulatory bodies, fostering productive relationships and proactive engagement•Assists, as needed, the Regulatory Affairs function, with quality related matters with any/all Form FDA 483 observations, Warning Letter, state board deficiency citations (in close collaboration with Regulatory Affairs, who leads the response to states)•Lead the development and execution of comprehensive remediation and quality improvement plans in response to audit observations, Warning Letters, 483s, or internally identified gaps•Stay abreast of evolving regulatory requirements, guidance documents, and industry standards, proactively adapting ReviveRX's quality strategies to maintain and strengthen compliance•Ensure the organization is in a continuous state of inspection readiness — not just pre-inspection preparation, but ready for an inspection at any time 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 through a robust quality risk management program to prioritize quality improvement investments•Develop advanced processes for the efficient and accurate recording of quality incidents, setting internal standards that reflect best-in-class pharmaceutical practices•Oversee the organization's change management program (i.e., change control, quality risk management of changes, and change implementation) Complaint Management & Patient Safety•Oversee ReviveRX's complaint management program, ensuring all product and service complaints are properly logged, tracked, trended, and acted upon in full compliance with USP <797>, <795>, and applicable State and Federal laws and regulations•Ensure the organization has robust processes for evaluating adverse events, determining appropriate regulatory reporting obligations, and escalating serious patient safety concerns to executive leadership and regulatory authorities as required•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 functionQualificationsEducation•Bachelor's degree in Pharmaceutical Sciences, Chemistry, Life Sciences, Engineering, or related technical field - REQUIRED•Advanced degree (MS, PhD, PharmD, MBA) strongly preferred•Six Sigma certification (Green Belt or higher) a plus•PMP or equivalent project management certification a plus Experience - CRITICAL REQUIREMENTS•15+ years of progressive experience within the pharmaceutical and/or compounding industry - REQUIRED•Pharmaceutical industry experience strongly preferred; 503A and/or 503B compounding experience highly valued•Minimum 7-10 years in senior quality leadership roles with direct P&L or budget accountability - REQUIRED•Demonstrated experience owning regulatory inspection strategy and serving as the primary senior quality representative during FDA and/or state board inspections - REQUIRED•Proven track record of successfully managing regulatory observations, Warning Letters, 483s, or state board deficiencies - REQUIRED•Demonstrated experience building, scaling, and leading quality organizations in growth-stage or highly regulated environments•Direct experience with sterile and/or non-sterile compounding, pharmaceutical manufacturing, or specialty pharmaceutical operations strongly preferred•Track record of successful senior executive-level collaboration and influence Technical Expertise•Deep knowledge of applicable USP Standards (USP <797>, <795>, <800>, <1163>) as well as all applicable State and Federal laws and regulations•Knowledge of FDA CGMP regulations (21 CFR Parts 210/211) a significant plus•Comprehensive understanding of QMS design and management aligned with ICH Q10•Strong knowledge of quality risk management principles (ICH Q9) and their practical application•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)•Familiarity with electronic Quality Management System (eQMS) platforms and digital quality transformation•Understanding of 503A and 503B regulatory frameworks and their operational implications•Knowledge of state board of pharmacy requirements and multi-state licensure management Core Competencies•Exceptional executive leadership with the proven ability to coach, mentor, inspire, and develop quality leaders and teams at all levels - REQUIRED•Ability to influence at the CQO/CEO/COO/Board level through concise, executive-level communication of complex technical and regulatory matters - REQUIRED•Demonstrated ability to lead organizational change — translating quality strategy into sustained adoption, measurable improvement, and genuine culture change - REQUIRED•Strong organizational agility with proven ability to manage multiple priorities, stakeholders, and high-stakes deadlines in a fast-paced environment•Enterprise mindset: consistently optimizing quality decisions for overall company outcomes, not just departmental metrics•Systems thinking and continual improvement mindset — always asking how processes, structures, and capabilities can be made more robust•Ability to translate complex quality risks into clear, business-relevant decisions and recommendations for executive leadership•Resilience and composure under pressure, particularly during regulatory scrutiny, remediation activities, or organizational change•High personal integrity, unwavering ethical standards, and a strong quality backbone — willing to make and defend difficult quality decisions•Skilled in delivering concise, compelling executive-ready presentations on complex technical, regulatory, and quality topics•Treats colleagues, patients, and customers with courtesy and dignity•Communicates with tact, diplomacy, and professionalism•Models a positive, solutions-oriented attitudeWork EnvironmentThis is an onsite role based full-time in Houston, Texas. Given the scope of the quality organization, the scale of ongoing quality improvement and remediation activities, and the importance of daily engagement with the quality team, operations, and executive leadership, full-time on-site presence is strongly preferred. For the right candidate, limited hybrid flexibility may be considered on an exception basis. The role demands 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.Success Metrics (First 12-18 months)•Rapid and thorough assessment of ReviveRX's current quality organization, systems, and compliance posture — with a clear prioritized improvement roadmap delivered to CQO and Executive Leadership within 90 days•Measurable improvement in QMS maturity across all core elements: CAPA closure rates, investigation cycle times, overdue document reviews, batch release timeliness, and complaint response metrics•Successful navigation of any pending or scheduled regulatory inspections with zero repeat observations and a credible, on-time remediation response•Full compliance with all state licensure requirements and proactive management of any open state board correspondence or commitments•Establishment or significant enhancement of quality governance structures (management review, quality councils, escalation pathways)•Demonstrable improvement in cross-functional quality culture — measurable through operational leader engagement, speak-up culture indicators, and quality metric trends•High-performing, stable quality leadership team in place with clear development plans and reduced management dependency on the VP for day-to-day execution•Complaint management program fully compliant with USP requirements and operating with defined KPIs, trending cadence, and proactive adverse event identification\n\nWhy 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 Revive RX 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.

VP of Quality - Pharmaceutical / Compounding job opportunity at ReviveRX Pharmacy, LLC.

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