Quality Assurance Director - 174207

Responsibilities: for the Quality Assurance Director include Lead and manage Quality Assurance and Document Control personnel to ensure compliance with GMP standards. Oversee FDA, regulatory, customer, and internal inspections and audits. Ensure compliance with cGMP regulations and applicable US and EU regulatory requirements. Review, approve, and maintain quality documentation within electronic document control systems. Investigate quality events, deviations, CAPAs, and change controls. Collaborate cross-functionally with Manufacturing, Quality Control, Regulatory Affairs, and Operations teams. Drive continuous improvement initiatives to strengthen quality systems and inspection readiness. Required Qualifications for the Quality Assurance Director include Bachelor's degree in a scientific discipline required; Associate's degree considered with additional relevant experience. 8+ years of experience in a GMP-regulated pharmaceutical, biotechnology, or related environment. Experience working in an FDA-regulated environment. Proven experience leading and managing regulatory inspections and audits. Strong knowledge of cGMP requirements and US/EU regulatory standards. Experience with electronic document control systems; MasterControl preferred. 2+ years of supervisory or management experience overseeing QA teams preferred. Qualifications: for the Quality Assurance Director include Bachelor's degree in a scientific discipline required; Associate's degree considered with additional relevant experience. 8+ years of experience in a GMP-regulated pharmaceutical, biotechnology, or related environment. Experience working in an FDA-regulated environment. Proven experience leading and managing regulatory inspections and audits. Strong knowledge of cGMP requirements and US/EU regulatory standards. Experience with electronic document control systems; MasterControl preferred. 2+ years of supervisory or management experience overseeing QA teams preferred.