Manager QA - Nights

Role: Night Shift Manager of Quality Assurance overseeing GMP manufacturing compliance. Objectives: lead, develop, and manage QA personnel to ensure quality and regulatory standards are met during night operations. Responsibilities: manage daily QA operations, develop and interpret procedures, oversee change controls, conduct investigations, lead audits, and ensure compliance in manufacturing processes—particularly in biotech, with a focus on monoclonal antibody or biologic production. Requirements: high school diploma with 12+ years of QA/manufacturing experience, or relevant higher education with fewer years; proven leadership experience managing teams or projects, with a preference for 6+ years of biotech QA and 2+ years of supervisory roles. Qualifications: Bachelor’s in Life Sciences, Engineering, or related field preferred. High-value biopharma specifics: experience in biologics manufacturing, investigations, CAPA, validation, change control, and compliance with biotech regulations. Collaboration: Partner with internal management and project teams; may support incident triage and audits. Work setup: Night shift (6pm-2:30am), with some flexibility; travel not specified.