Executive Director, Quality Control

Role: Executive Director of Quality Control overseeing all QC functions from drug development to commercialization, including manufacturing, clinical trial support, and post-market activities. Responsibilities: lead microbiology and analytical labs, ensure compliance with GxP regulations, develop and validate analytical methods, oversee manufacturing and release testing, manage regulatory interactions, and drive continuous process improvements. Qualifications: Bachelor's in sciences/engineering with 15+ years biotech/pharma experience or PhD with 5+ years; senior leadership experience in quality, with global GxP regulatory expertise. High-Value: focus on biologics and drug products, with responsibilities spanning clinical and commercial phases, regulatory agency interactions (FDA, EMA), and compliance across GxP disciplines. Preferred skills include experience with biological assays, statistical tools like JMP, and cell-based potency assays. The role involves strategic leadership, cross-functional collaboration, and oversight of microbiology, analytical development, and manufacturing operations, with a focus on ensuring product quality and regulatory compliance.