Quality Assurance Director

Responsibilities: Lead and manage Quality Assurance and Document Control personnel Oversee FDA, regulatory, customer, and internal inspections and audits Ensure compliance with cGMP regulations and US/EU regulatory requirements Review, approve, and maintain quality documentation within electronic document control systems Investigate quality events, deviations, CAPAs, and change controls Collaborate with Manufacturing, QC, Regulatory Affairs, and Operations Drive continuous improvement initiatives and maintain inspection readiness Required Qualifications Bachelor's degree in a scientific discipline required 8+ years of experience in GMP-regulated pharmaceutical, biotechnology, or related environments Experience working in FDA-regulated settings Experience leading audits and regulatory inspections Strong knowledge of cGMP regulations and US/EU standards Electronic document control system experience (MasterControl preferred) 2+ years of management or supervisory experience preferred Qualifications: Bachelor's degree in a scientific discipline required 8+ years of experience in GMP-regulated pharmaceutical, biotechnology, or related environments Experience working in FDA-regulated settings Experience leading audits and regulatory inspections Strong knowledge of cGMP regulations and US/EU standards Electronic document control system experience (MasterControl preferred) 2+ years of management or supervisory experience preferred