Supervisor, Quality Operations

Empower Pharmacy
  • Houston, Texas
    30+ days ago

    Job Description

    Empower Pharmacy is a visionary healthcare company dedicated to making quality, affordable medication accessible to millions of patients nationwide. As the nation’s most advanced 503A compounding pharmacy and FDA-registered 503B outsourcing facility, we’re redefining what’s possible in personalized medicine and pharmaceutical manufacturing. We’re proud to be recognized as one of Houston’s fastest-growing private companies and ranked #116 in Healthcare & Medical on the Inc. 5000 List for 2025.

    Our strength is built on four core values: People, Quality, Service, and Innovation. Guided by these principles, we’ve created a uniquely integrated healthcare platform powered by advanced technology, operational excellence, and a relentless commitment to patient care. From manufacturing and quality control to distribution and customer experience, our teams work together to raise industry standards, expand access to critical medications, and improve outcomes for patients and providers across the country.

    At Empower, joining our team means more than starting a new role. It means becoming part of a mission-driven organization that’s transforming healthcare at scale. We invest deeply in our people, encourage bold thinking, and create opportunities for growth, leadership, and innovation at every level. Your ideas matter here, your development is supported, and the work you do has a direct impact on the lives of millions.

    If you thrive in a fast-moving, purpose-driven environment where innovation, collaboration, and ambition come together, Empower Pharmacy is the place for you. Let’s transform healthcare together.

    POSITION SUMMARY

    As Supervisor, Quality Operations, you lead frontline quality execution across aseptic manufacturing, ensuring compliant, timely, and risk-based decisions that directly protect product quality, patient safety, regulatory readiness, and business performance. You own daily oversight of batch record review, deviation management, investigations, CAPA effectiveness, lot disposition, and quality system execution across a multi-shift operation. Leveraging AI as a force multiplier, you enhance review speed, decision quality, trend detection, knowledge access, and operational scalability while maintaining human accountability for regulated outcomes. Operating within Empower’s hyper-growth 503A and 503B environment, you drive disciplined execution, continuous improvement, and inspection readiness. Success requires talent capable of strategic thinking, execution rigor, learning agility, cross-functional influence, and consistent delivery in complex, fast-evolving, highly regulated settings while developing teams, strengthening collaboration, and accelerating measurable results at scale.

    RESPONSIBILITIES

    Quality Execution

    • Batch Oversight: Lead daily review and disposition activities across manufacturing operations, ensuring batch documentation accuracy, data integrity, and compliance with established quality standards. Utilize AI-enabled review tools to accelerate record assessment, identify anomalies, prioritize risk, and improve decision consistency while maintaining accountability for final quality determinations, cycle-time performance, and regulatory readiness.
    • Deviation Leadership: Direct investigations related to deviations, excursions, nonconformances, and quality events, ensuring timely containment, root cause identification, and effective resolution. Leverage AI-supported analytics to uncover trends, strengthen investigative rigor, improve documentation quality, and accelerate issue resolution while ensuring actions align with regulatory expectations, operational priorities, and patient safety requirements.
    • Release Management: Oversee lot disposition activities and release workflows to ensure products meet quality requirements before distribution. Apply data-driven and AI-assisted insights to evaluate risk, streamline review processes, and improve release efficiency while maintaining compliance, protecting product quality, and supporting reliable supply within a rapidly scaling manufacturing environment.

    Quality Systems

    • CAPA Governance: Supervise corrective and preventive action processes from initiation through effectiveness verification, ensuring sustainable solutions address underlying causes. Use AI-driven pattern recognition and trend analysis to identify recurring issues, strengthen preventive strategies, improve execution quality, and support continuous improvement initiatives that enhance operational performance and compliance outcomes.
    • Change Control: Review and approve quality-related changes, ensuring appropriate risk assessment, stakeholder alignment, and regulatory compliance. Leverage AI-enhanced knowledge management tools to evaluate historical outcomes, identify potential impacts, and support informed decision-making while maintaining control, consistency, and effectiveness across quality systems and manufacturing processes.
    • Compliance Monitoring: Maintain oversight of cGMP adherence, procedural compliance, and quality system effectiveness across assigned operations. Utilize AI-enabled monitoring capabilities to identify emerging risks, prioritize corrective actions, and improve visibility into compliance performance while supporting inspection readiness, audit preparedness, and sustained operational excellence.

    People Leadership

    • Team Development: Lead, coach, and develop quality professionals through performance management, training, and cross-functional collaboration. Foster a high-accountability culture where AI tools enhance productivity, learning, and decision support while employees strengthen technical expertise, problem-solving capabilities, and ownership of quality outcomes in a highly regulated environment.
    • Talent Excellence: Build a high-performing team aligned to Empower’s P80–P90 talent expectations by reinforcing strategic thinking, execution discipline, and learning agility. Create opportunities for growth, knowledge sharing, and capability development while leveraging technology and AI to increase effectiveness, scalability, and organizational impact.
    • Cross Functional: Partner closely with Manufacturing, Validation, Engineering, Laboratory, and Regulatory teams to resolve issues, improve processes, and drive business objectives. Utilize AI-supported collaboration and data-sharing tools to accelerate decisions, improve communication quality, and strengthen alignment across functions while maintaining quality-first outcomes.

    Continuous Improvement

    • Process Optimization: Identify opportunities to improve workflows, eliminate inefficiencies, and strengthen quality performance across operations. Apply AI-enabled analytics, automation, and process intelligence to accelerate cycle times, improve consistency, reduce manual effort, and enhance overall effectiveness while preserving compliance and quality standards.
    • Risk Management: Drive proactive risk identification, assessment, and mitigation activities across quality operations. Utilize predictive analytics and AI-assisted trend monitoring to detect emerging concerns, prioritize actions, and support informed decision-making that reduces operational risk, protects product quality, and strengthens regulatory confidence.
    • Inspection Readiness: Ensure continuous preparedness for internal audits, customer assessments, and regulatory inspections through disciplined execution and documentation practices. Leverage AI-powered knowledge retrieval, compliance monitoring, and trend analysis tools to strengthen readiness, improve response quality, and support successful inspection outcomes within a hyper-growth environment.

    KNOWLEDGE AND SKILLS

    • Advanced knowledge of cGMP regulations, aseptic manufacturing, quality systems, investigations, CAPA management, batch record review, and risk-based decision-making within highly regulated production environments.
    • Proficiency with quality management systems, electronic documentation platforms, data analytics tools, and AI-enabled technologies that improve compliance monitoring, workflow efficiency, and operational visibility.
    • Strong leadership, coaching, communication, and stakeholder management capabilities with the ability to influence outcomes, resolve complex issues, and drive accountability across cross-functional teams.
    • Demonstrated ability to analyze data, identify trends, manage competing priorities, and execute continuous improvement initiatives while maintaining quality, compliance, and business performance objectives.

    EXPERIENCE AND QUALIFICATIONS

    • Minimum of 3 years of experience in pharmaceutical quality, including 2 years in a supervisory role.
    • Bachelor of Science degree in a technical or scientific discipline. 
    • American Society for Quality (ASQ) Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or an equivalent certification preferred.
    • Possesses knowledge of pharmaceutical manufacturing, United States Pharmacopeia <797>, cGMP, Food and Drug Administration regulations (21 Code of Federal Regulations Parts 210, 211), and International Council for Harmonisation regulations, with proficiency in computer software, particularly SharePoint.

    Key Competencies:

    • Customer Focus: Builds trust through customer-centric solutions.
    • Strategic AI: Guides responsible AI adoption and adaptation.
    • Optimizes Work Processes: Drives efficiency with continuous improvement.
    • Collaborates: Partners effectively to achieve shared goals.
    • Resourcefulness: Secures and deploys resources efficiently.
    • Manages Complexity: Simplifies and solves complex challenges.
    • Ensures Accountability: Delivers on commitments with integrity.
    • Situational Adaptability: Adjusts approach to shifting conditions.
    • Communicates Effectively: Tailors messages to diverse audiences.

    Values:

    • People: Empowering people defines who we are.
    • Quality: Excellence in every product, every time.
    • Service: Serving others is our highest purpose.
    • Innovation: Advancing care through technology and discovery.

    Employee Benefits, Health and Wellness:

    We offer comprehensive benefits to support your health, well-being, and future, including medical, dental, and vision coverage, paid time off, 401(k) matching, wellness perks, IV therapy, and compounded medications. Learn more: https://careers.empowerpharmacy.com/benefits/

    Physical Requirements:

    While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. Employees are regularly required to move about the office and around the corporate campus. The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl.

    Numbers & Facts

    LocationHouston, Texas
    Websitehttps://careers.empowerpharmacy.com/jobs/

    Skills

    • American Society for Quality (ASQ)unmatched
    • Artificial Intelligence (AI)unmatched
    • Asepsisunmatched
    • Auditingunmatched
    • Automationunmatched
    • Biotech and Pharmaceuticalunmatched
    • Change Controlunmatched
    • Coachingunmatched
    • Code of Federal Regulationsunmatched
    • Communication Skillsunmatched
    • Computer Skillsunmatched
    • Computer Softwareunmatched
    • Continuous Improvementunmatched
    • Corrective Actionunmatched
    • Corrective and Preventative Action (CAPA) Systemsunmatched
    • Cross-Functionalunmatched
    • Current Good Manufacturing Practice (cGMP)unmatched
    • Customer Experienceunmatched
    • Customer Relationsunmatched
    • Data Analysisunmatched
    • Data Qualityunmatched
    • Decision Supportunmatched
    • Distribution Controlunmatched
    • Documentationunmatched
    • Drug Manufacturingunmatched
    • Establish Prioritiesunmatched
    • FDA (Food and Drug Administration)unmatched
    • Financial Trend Analysisunmatched
    • Healthcareunmatched
    • Identify Issuesunmatched
    • Industry Standardsunmatched
    • Information Retrievalunmatched
    • Internal Auditunmatched
    • Knowledge Managementunmatched
    • Leadershipunmatched
    • Maintain Complianceunmatched
    • Manufacturingunmatched
    • Manufacturing Operationsunmatched
    • Manufacturing Requirementsunmatched
    • Manufacturing Systemsunmatched
    • Manufacturing/Industrial Processesunmatched
    • Medicationsunmatched
    • Microsoft SharePointunmatched
    • Operational Strategyunmatched
    • Operations Managementunmatched
    • Organizational Development/Managementunmatched
    • Outsourcingunmatched
    • Patient Careunmatched
    • Patient Safetyunmatched
    • Pattern Matchingunmatched
    • Performance Managementunmatched
    • Pharmacyunmatched
    • Physical Demandsunmatched
    • Predictive Modelingunmatched
    • Problem Solving Skillsunmatched
    • Process Developmentunmatched
    • Process Improvementunmatched
    • Product Supportunmatched
    • Production Systemsunmatched
    • Quality Assuranceunmatched
    • Quality Controlunmatched
    • Quality Managementunmatched
    • Quality Metricsunmatched
    • Regulationsunmatched
    • Regulatory Complianceunmatched
    • Release Management/Engineeringunmatched
    • Riskunmatched
    • Risk Analysisunmatched
    • Risk Managementunmatched
    • Root Cause Analysisunmatched
    • Safety Trainingunmatched
    • Team Buildingunmatched
    • Time Managementunmatched
    • Trend Analysisunmatched

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