Director, Quality Control 503A - 503B

Empower Pharmacy•Houston, TX

2d•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.

Requirements

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.
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.

Nice To Haves

Master’s degree in related field or Master of Business Administration.
Certified Quality Auditor (CQA) preferred.

Responsibilities

Define an integrated laboratory strategy across 503A and 503B facilities, balancing internal capabilities, external partnerships, testing demand, regulatory needs, and business growth priorities.
Establish multiyear capability plans that expand chemical and microbiological testing, strengthen operational resilience, and align laboratory investments with enterprise objectives and future demand.
Evaluate network performance and recommend capacity, sourcing, technology, or process changes that improve quality, cost, service, scalability, and turnaround time across facilities.
Set performance targets for laboratory quality, cost, service, productivity, and turnaround time, using defined measures to drive accountability and sustained improvement across operations.
Advance laboratory systems, methodologies, and technologies that improve testing reliability, workflow efficiency, data quality, and decision speed without weakening controls or human oversight.
Lead continuous improvement initiatives by identifying process constraints, prioritizing corrective opportunities, and confirming implemented changes achieve measurable operational and quality outcomes consistently.
Oversee chemical and microbiological testing programs across both facility types, ensuring methods, specifications, documentation, and results meet applicable requirements and business needs consistently.
Direct stability program design and execution supporting research and development, technical transfers, routine production, and reliable shelf-life determinations for the commercial product portfolio.
Review laboratory performance trends, investigations, deviations, and recurring issues to identify risk, strengthen controls, and improve the reliability of reported results enterprise-wide.
Ensure laboratory operations comply with applicable federal, state, and compounding pharmacy requirements, including USP <795>, <797>, and <800>, as relevant to each facility.
Maintain effective quality control practices for method governance, documentation, data integrity, investigations, change implementation, and inspection readiness across laboratory operations and partnerships.
Partner with Quality Assurance, Operations, Regulatory, Research and Development, and other stakeholders to resolve risks, coordinate priorities, and support compliant execution enterprise-wide.
Build and develop a high-performing laboratory organization through clear accountability, technical training, coaching, succession planning, and consistent performance expectations across facilities and teams.
Strengthen internal expertise in laboratory operations, compounding requirements, analytical methods, microbiology, stability programs, and quality systems through targeted capability development and mentoring.
Manage external contract laboratories through defined expectations, performance reviews, issue resolution, and risk-based oversight that protects quality, service, cost, and supply continuity.