Manager, Analytical Quality Assurance

Role: Analytical Quality Assurance (AQA) Manager overseeing QA review and approval of GMP analytical documents for biologics and small molecules throughout the product lifecycle. Responsibilities: review and approve validation protocols, change controls, procedures, reports, CoAs, and reference materials; collaborate with analytical and operational teams to resolve deviations and CAPAs; ensure compliance with FDA and GxP regulations; contribute to continuous improvement initiatives. Requirements: minimum of 5 years in biologics/small molecule QA, QC, or analytical chemistry; experience with electronic QMS systems (e.g., Veeva, Trackwise); strong understanding of GxP and FDA guidelines; excellent communication and problem-solving skills; ability to manage multiple priorities under tight timelines. HighValue: GMP analytical method validation, technical documentation review, biologics/small molecules, FDA/GxP compliance, electronic document systems. WorkSetup: location flexible within US (Devens, MA or New Brunswick, NJ); full-time, with potential for flexible work arrangements.