Hiring: Quality Systems Manager/Senior Manager Company: Obsidian Therapeutics Location: Bedford, MA Job Posted Time: 2026-09-10 15:08:20 Employment Type: Hybrid Target Skills & Keywords : Change Management, Project Management, Root Cause Analysis About the job Experience: •6+ years of experience in QA within clinical late stage biopharmaceutical environments •3+ years of direct process ownership or administration of quality systems, including change control Required Skills: •Manage the Quality Management System (QMS), serving as process owner for Change Control, Product Complaints, Deviations, Corrective and Preventive Actions (CAPA), Vendor Notifications, and Quality Management Review (QMR). •Ensure quality system processes remain compliant with applicable FDA, ICH, and GxP requirements while maintaining inspection readiness. •Author, revise, and maintain SOPs, forms, templates, training materials, and other quality system documentation. •Monitor quality system performance, identify systemic process issues, and drive continuous improvement initiatives. •Support internal audits, external audits, and regulatory inspections. •Serve as the Quality business lead for eQMS selection, implementation, validation, deployment, and ongoing optimization. •Partner with Digital Solutions & Technology, Regulatory Affairs, Manufacturing, Supply Chain, QC, and QA stakeholders to define business requirements and future-state workflows. •Lead process mapping, workflow design, system configuration, validation activities, data migration, training, communication, and change management efforts to ensure successful adoption. Qualifications: •Bachelor's degree and 6+ years of experience in QA within clinical late stage biopharmaceutical environments •Successful experience leading or playing a significant role in implementation of an eQMS •Management of systems such as Veeva, MasterControl, TrackWise, or equivalent platforms •Strong working knowledge of FDA, EU GMP, ICH, and applicable GxP regulations •Excellent planning, coordination, and time management skills •Excellent oral, written, and visual communication skills. You listen to understand and communicate effectively and persuasively with partners, colleagues, and leadership. •Demonstrated capacity to build and maintain productive relationships with department management, peers, and other colleagues across the organization •Collaborative and accountable – recognizes success requires teamwork and interdisciplinary thinking; shares feedback and ideas to facilitate better outcomes •Self-motivated, with a proven ability to meet objectives, timelines, and high standards managing multiple responsibilities in parallel. •Flexible - adapts to change in a fast paced, rapidly developing environment Compensation: •$117,000 - $165,000 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!