Director, Quality Control 503A - 503B
Core
Leads laboratory quality control strategy across 503A and 503B facilities, ensuring testing operations protect product quality, patient safety, and regulatory compliance.
Role type
Director, Quality Control (Pharmaceutical Manufacturing) (via careerplan.io/jobs/4433262009-director-quality-control-503a-503b-at-empowerpharmacy)
Builds
Internal and external laboratory network for chemical, microbiological, and stability testing
Domain
Healthcare / Pharmaceutical Compounding (503A/503B)
Required skills
Strategic planning, regulatory compliance (USP <795>, <797>, <800>), laboratory operations management, team leadership, process improvement, risk resolution, external partner oversight, data analysis
Preferred skills
Certified Quality Auditor (CQA), MBA, advanced data analysis
Technologies
High-Performance Liquid Chromatography, Gas Chromatography, Microsoft Office Suite
Responsibilities
Define integrated laboratory strategy across facilities, establish multiyear capability plans, oversee chemical and microbiological testing programs, direct stability program design, ensure regulatory alignment with federal/state requirements, build and develop high-performing laboratory organization, manage external contract laboratories
Seniority
Director, strategic leadership & operational oversight