Director of Quality Control 503A - 503B

POSITION SUMMARY:

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.

RESPONSIBILITIES:

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.  

EXPERIENCE AND 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.