Manager, Quality Assurance

Role: Quality Assurance (QA) Leader overseeing GMP and GLP compliance within biopharma manufacturing. Objectives: ensure product quality, regulatory adherence, and continuous process improvement. Responsibilities: supervise QA staff, review controlled documents (SOPs, specifications), manage compliance programs, analyze manufacturing and quality data, lead investigations and CAPAs, and coordinate with R&D and contract manufacturers for new product launches and audits. Requirements: 7+ years in GMP environment, BS/BA degree; 5+ years with MS. Preferred skills include deep knowledge of GMPs/GLPs, QA principles, industry standards, and statistical tools like Six Sigma and FMEA; strong project management, communication, and technical writing skills. High-value specifics: focus on manufacturing quality in biopharma, experience with quality systems regulations, and compliance audits. Work setup and travel details are not specified.