Director, Quality Assurance

Empower Pharmacy•Houston, TX

4d•Onsite

About The Position

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.

Requirements

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.
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.

Nice To Haves

Lean Six Sigma Green Belt, Certified Pharmaceutical Industry Professional (CPIP), Professional Engineer (PE), or Certified Quality Engineer (CQE) certification preferred.

Responsibilities

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.
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.
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.
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.
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.
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.
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.
Oversees deviations, investigations, CAPAs, and change controls.
Applies AI-powered analytics to improve root cause identification, strengthen corrective actions, and enhance quality system effectiveness.
Leads risk management efforts to identify compliance vulnerabilities and operational gaps.
Leverages predictive analytics to improve mitigation planning and support resilient quality operations.
Partners cross-functionally to integrate quality requirements into business processes.
Utilizes AI-enabled collaboration tools to improve alignment and support compliant execution.
Establishes KPIs to monitor quality performance and compliance trends.
Applies AI-powered dashboards to improve visibility and support data-driven decisions.
Drives initiatives improving quality systems and operational efficiency.
Leverages AI analytics and structured methodologies to strengthen outcomes and support growth.
Builds high-performing quality teams that foster accountability and continuous improvement.
Utilizes AI-enabled workforce analytics to improve engagement and capability.
Aligns quality priorities with executive and cross-functional teams.
Leverages AI-enabled tools to improve communication and decision-making.
Provides updates on quality performance and compliance risks.
Uses AI-powered reporting tools to improve visibility and support business planning.