Director, Quality Control 503A - 503B
About the role
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,