VP of Quality - Pharmaceutical / Compounding

ReviveRX and Ways2Well•Houston, TX

6d•Onsite

About The Position

At ReviveRX, we exist for the patients who fall through the cracks of conventional medicine â the ones who need something more precise, more personal, more them. As a leading licensed mail-order pharmacy specializing in both generic and compounded medications, we don't just fill prescriptions. We craft solutions. Every medication is tailored to the unique biology, needs, and life of a real person â because that's what personalized medicine actually means. Our mission: Equip providers with safe, innovative options and deliver an exceptional experience from the moment a prescription is written to the moment it arrives at a patient's door. Founded in 2016 and compounding since 2018, ReviveRX has built a team of dedicated professionals all driven by one uncompromising standard: excellence. We work closely with best-in-class pharmacists, scientists, healthcare providers, and pharmaceutical manufacturers to ensure every product we deliver is high-quality and dependable. Quality isn't a checkbox here. It's our culture. Our compounds are expertly crafted in USP-certified clean rooms at our Houston headquarters â built to meet the most rigorous standards in the industry. Every single batch undergoes sterility and endotoxin testing to ensure the highest levels of compliance, efficacy, and patient safety. We understand the trust providers place in us, and we honor that responsibility with precision and transparency. That trust isn't given. It's earned, every day. Providers come to us for our clinical quality. They stay because of our service, our responsiveness, and the way we show up as true partners in care. Whether you're just exploring personalized medicine or you've been a compounding advocate for years â welcome to the ReviveRX difference. The 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 â 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.

Requirements

Bachelor's degree in Pharmaceutical Sciences, Chemistry, Life Sciences, Engineering, or related technical field - REQUIRED
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
Deep knowledge of applicable USP Standards (USP <797>, <795>, <800>, <1163>) as well as all applicable State and Federal laws and regulations
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 â 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 â 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 â 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 attitude

Nice To Haves

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
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
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

Responsibilities

Set the strategic vision, direction, and roadmap for ReviveRX's entire quality organization â 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 â 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 â not a QA-only function â 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
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 â Sterile Preparations, USP <795> Pharmaceutical Compounding â 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
Serve as ReviveRX's senior representative during FDA, state board of pharmacy, and other regulatory inspections â 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 â not just pre-inspection preparation, but ready for an inspection at any time
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)
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 â identifying patterns, informing CAPA priorities, and driving systemic process improvements
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 â ensuring an enterprise-wide understanding that quality is everybody's responsibility
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 â 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
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