Director, Quality Assurance

JobRx, Inc.; Houston (TX); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Paid time off

401(k) matching

Wellness perks

IV therapy

Compounded medications

Job summary

Empower Pharmacy is a leading healthcare company focused on advancing quality and access to medications. The Director, Quality Assurance drives regulatory compliance and inspection readiness across 503A and 503B operations, overseeing quality systems, supplier quality, validation, and governance, leveraging AI-enabled analytics to improve decision-making and execution.

This role requires strategic thinking, leadership in a hyper-growth, regulated environment, and a proven track record in

Qualifications

• Bachelor's degree in scientific or technical discipline required.
• Minimum 10 years of pharmaceutical quality experience, including regulatory inspection leadership.
• Experience overseeing quality systems, supplier quality, validation, and compliance programs.
• Experience implementing digital quality systems and process improvements preferred.

Responsibilities

• Leads Quality Assurance operations ensuring compliance with FDA regulations, cGMP, and standards.
• Directs inspection readiness, including audits and response management.
• Oversees internal audit programs, CAPA, and continuous improvement initiatives.
• Directs supplier quality programs, including qualification, monitoring, and auditing.
• Provides leadership for validation activities including equipment, process, and system validation.

Skills

Quality Assurance

FDA regulations

cGMP

Audit governance

Supplier quality

Validation

Regulatory compliance

AI analytics

Leadership

Quality systems

Education

Bachelor's degree in scientific or technical discipline

Tools

AI analytics tools

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

The Director, Quality Assurance drives quality performance, regulatory compliance, and inspection readiness across Empower's 503A and 503B operations. This role owns quality systems, audit governance, supplier quality, validation oversight, and compliance execution supporting patient safety and business growth. Leveraging AI-enabled analytics, predictive monitoring, and digital quality systems, the position improves decision‑making, compliance visibility, and execution consistency. Success requires strategic thinking, execution rigor, learning agility, and leadership within a hyper‑growth, regulated environment. Talent demonstrates accountability, operational discipline, and quality leadership supporting compliance excellence, inspection readiness, and enterprise performance.

RESPONSIBILITIES

Quality Leadership

• Quality Oversight: Leads Quality Assurance operations ensuring compliance with FDA regulations, cGMP requirements, and industry standards. Utilizes AI-enabled analytics and monitoring tools to strengthen compliance visibility, improve execution consistency, reduce regulatory risk, and support scalable quality performance while maintaining product integrity and patient safety across regulated manufacturing environments.
• Inspection Leadership: Directs inspection readiness, including preparation, execution, and response management for audits. Leverages AI-powered compliance tools and reporting platforms to improve readiness visibility, accelerate remediation, strengthen documentation accuracy, and ensure successful inspection outcomes while reinforcing enterprise quality systems.
• Audit Governance: Oversees internal audit programs that assess quality systems and compliance. Applies AI-assisted analytics to identify gaps, improve processes, accelerate issue resolution, and reinforce continuous improvement initiatives supporting enterprise compliance and operational performance.

Quality Systems

• Supplier Quality: Directs supplier quality programs, including qualification, monitoring, and auditing across vendors. Utilizes AI-enabled analytics and dashboards to improve supplier oversight, mitigate risks, and ensure consistent product quality across the supply chain.
• Validation Oversight: Provides leadership for validation activities including equipment, process, and system validation. Leverages AI-powered analytics to improve process robustness, strengthen compliance, reduce variability, and support reliable manufacturing performance.
• Systems Management: Oversees quality systems, including training, document control, and records management. Applies AI-enabled automation and digital tools to improve efficiency, strengthen data integrity, and support scalable quality operations.

Regulatory Compliance

• Compliance Execution: Ensures adherence to FDA regulations, USP standards, and cGMP practices. Utilizes AI-enabled monitoring and analytics to strengthen compliance execution, improve oversight, and reduce regulatory risk.
• CAPA Management: Oversees deviations, investigations, CAPAs, and change controls. Applies AI-powered analytics to improve root cause identification, strengthen corrective actions, and enhance quality system effectiveness.
• Risk Governance: Leads risk management efforts to identify compliance vulnerabilities and operational gaps. Leverages predictive analytics to improve mitigation planning and support resilient quality operations.

Operational Excellence

• Process Integration: Partners cross-functionally to integrate quality requirements into business processes. Utilizes AI-enabled collaboration tools to improve alignment and support compliant execution.
• Performance Metrics: Establishes KPIs to monitor quality performance and compliance trends. Applies AI-powered dashboards to improve visibility and support data-driven decisions.
• Continuous Improvement: Drives initiatives improving quality systems and operational efficiency. Leverages AI analytics and structured methodologies to strengthen outcomes and support growth.

Leadership & Development

• Team Leadership: Builds high-performing quality teams that foster accountability and continuous improvement. Utilizes AI-enabled workforce analytics to improve engagement and capability.
• Stakeholder Alignment: Aligns quality priorities with executive and cross-functional teams. Leverages AI-enabled tools to improve communication and decision-making.
• Strategic Communication: Provides updates on quality performance and compliance risks. Uses AI-powered reporting tools to improve visibility and support business planning.

KNOWLEDGE AND SKILLS

• Expertise in quality systems, cGMP, USP standards, audit management, and regulatory compliance within pharmaceutical environments.
• Proficiency with AI-enabled analytics, digital quality systems, and workflow automation to improve compliance and decision-making.
• Strong leadership and communication skills, with the ability to align cross-functional teams and driving quality initiatives.
• Analytical mindset with experience implementing scalable quality and compliance strategies.

EXPERIENCE AND QUALIFICATIONS

• Bachelor's degree in scientific or technical discipline required.
• Minimum 10 years of pharmaceutical quality experience, including regulatory inspection leadership.
• Experience overseeing quality systems, supplier quality, validation, and compliance programs.
• Experience implementing digital quality systems and process improvements preferred.
• Proven ability to lead teams and drive measurable quality and compliance outcomes.
• Lean Six Sigma Green Belt, Certified Pharmaceutical Industry Professional (CPIP), Professional Engineer (PE), or Certified Quality Engineer (CQE) certification preferred.

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.