Sr Manager, QA Operations

Role: Senior Manager of Quality Assurance Operations overseeing GMP QA at a vaccine Drug Substance manufacturing site. Responsibilities: provide senior oversight of manufacturing activities, manage deviations, CAPAs, change controls, validation, risk assessments, and ensure regulatory compliance; support inspection readiness, audits, and internal/external projects including tech transfers and supplier interactions; lead and develop QA personnel, foster a quality culture, and ensure operational excellence. Requirements: Bachelor's in Biological Sciences, Chemistry, Engineering, or related field; 8–10+ years GMP QA experience supporting biologics or vaccines, with proven leadership in regulated manufacturing environments; supporting regulatory inspections, audits, validation, and technical transfers. Skills: strong CGMP knowledge, risk assessment, complex data interpretation, excellent communication, cross-functional collaboration, and proficiency in eQMS and MS Office. High-value specifics: biologics/vaccine focus, Drug Substance manufacturing, regulatory inspection support, validation oversight, and quality systems leadership. Work setup: location not specified; likely on-site with cross-training to ensure continuity.