Associate Director Quality

Role: Associate Director of Quality overseeing site compliance within a biopharma manufacturing environment, with a focus on maintaining regulatory standards and continuous quality improvement. Responsibilities: provide quality direction, manage documentation, conduct audits, ensure GMP compliance, lead quality systems including change control, and supervise Quality Specialists partnering with operations teams. Requirements: Bachelor's in science or engineering with 8+ years of relevant experience; strong knowledge of cGMP, FDA, and EMEA regulations; at least 2 years in GMP-controlled environments. Preferred: leadership of teams, experience with aseptic/sterile processing, lean principles (LSS Green Belt), and biologics or vaccine manufacturing experience. High-Value: biologics or vaccine production, GMP compliance, quality management systems, regulatory audits, risk and deviation management, cross-functional collaboration, and 10% travel. Work Setup: on-site, with travel as needed.