Director, Quality Control 503A - 503B
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 OVERVIEW:
The Director of Quality Control leads Empower’s laboratory quality control strategy across 503A and 503B facilities, ensuring testing operations protect product quality, patient safety, regulatory compliance, and reliable supply. This role owns the internal and external laboratory network, establishes performance expectations, and advances chemical, microbiological, and stability testing capabilities. The Director translates business priorities and regulatory requirements into scalable laboratory systems, disciplined execution, and measurable improvements in quality, cost, service, and turnaround time. Success requires strategic judgment, technical depth, cross-functional leadership, and rigorous oversight of testing methods, data integrity, investigations, and external partners. In Empower’s hyper-growth, highly regulated compounding environment, the Director builds organizational capability, anticipates risk, accelerates sound decisions, and strengthens laboratory performance across distinct operating models while maintaining accountability for compliant, accurate, and timely results enterprise-wide at every stage.
Essential Job Functions:
Laboratory Strategy
- Network Strategy: Define an integrated laboratory strategy across 503A and 503B facilities, balancing internal capabilities, external partnerships, testing demand, regulatory needs, and business growth priorities.
- Capability Planning: Establish multiyear capability plans that expand chemical and microbiological testing, strengthen operational resilience, and align laboratory investments with enterprise objectives and future demand.
- Network Optimization: Evaluate network performance and recommend capacity, sourcing, technology, or process changes that improve quality, cost, service, scalability, and turnaround time across facilities.
Operational Excellence
- Performance Management: Set performance targets for laboratory quality, cost, service, productivity, and turnaround time, using defined measures to drive accountability and sustained improvement across operations.
- Systems Advancement: Advance laboratory systems, methodologies, and technologies that improve testing reliability, workflow efficiency, data quality, and decision speed without weakening controls or human oversight.
- Process Improvement: Lead continuous improvement initiatives by identifying process constraints, prioritizing corrective opportunities, and confirming implemented changes achieve measurable operational and quality outcomes consistently.
Testing Programs
- Testing Oversight: Oversee chemical and microbiological testing programs across both facility types, ensuring methods, specifications, documentation, and results meet applicable requirements and business needs consistently.
- Stability Governance: Direct stability program design and execution supporting research and development, technical transfers, routine production, and reliable shelf-life determinations for the commercial product portfolio.
- Trend Evaluation: Review laboratory performance trends, investigations, deviations, and recurring issues to identify risk, strengthen controls, and improve the reliability of reported results enterprise-wide.
Quality Compliance
- Regulatory Alignment: Ensure laboratory operations comply with applicable federal, state, and compounding pharmacy requirements, including USP <795>, <797>, and <800>, as relevant to each facility.
- Control Governance: Maintain effective quality control practices for method governance, documentation, data integrity, investigations, change implementation, and inspection readiness across laboratory operations and partnerships.
- Risk Resolution: Partner with Quality Assurance, Operations, Regulatory, Research and Development, and other stakeholders to resolve risks, coordinate priorities, and support compliant execution enterprise-wide.
Organizational Leadership
- Team Development: Build and develop a high-performing laboratory organization through clear accountability, technical training, coaching, succession planning, and consistent performance expectations across facilities and teams.
- Technical Capability: Strengthen internal expertise in laboratory operations, compounding requirements, analytical methods, microbiology, stability programs, and quality systems through targeted capability development and mentoring.
- Partner Oversight: Manage external contract laboratories through defined expectations, performance reviews, issue resolution, and risk-based oversight that protects quality, service, cost, and supply continuity.
Knowledge and Skills:
- Demonstrates strong leadership abilities, strategic planning, problem-solving, and collaboration skills, with a focus on continuous improvement and effective team management.
- Required experience applying compounding pharmacy regulations and laboratory quality systems across 503A and 503B facilities or comparable regulated operating models.
- Possesses deep expertise in compounding pharmacy regulations (United States Pharmacopeia <797>, <795>, <800>), laboratory systems, testing methods (High-Performance Liquid Chromatography, Gas Chromatography, microbiological testing), and quality systems, with proficiency in Microsoft Office Suite and advanced data analysis.
Qualifications:
- Minimum 10 years of experience in pharmaceutical quality control or assurance, including expertise in laboratory operations, regulatory compliance, and stability programs, with at least 2 years in senior leadership driving team management and strategic initiatives.
- Bachelor’s degree in Pharmacy, Chemistry, Biology, Microbiology, or a related field. Master’s degree in related field or Master of Business Administration.
- Certified Quality Auditor (CQA) 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.