About this role
Director, Quality Assurance & Compliance at Promega. Location: Madison, Wisconsin, United States. Role: lead inspections, develop QMS, manage CAPA Requirements: Bachelor’s in life sciences; 10+ years QA in pharma with 5+ in leadership; NDA/BLA regulatory submissions; FDA BIMO inspections; GxP knowledge (GMP, GCP, GLP); 21 CFR parts 50,56,312; eQMS admin; strong regulatory writing; AI/Regulatory tech experience. Category: Research and Development (R&D) Seniority: Senior Level Tools: ETQ, MasterControl, Veeva, eQMS, AI tooling Certifications: cqa (certified quality auditor) Commitment: Full Time Workplace: Onsite Languages: English