Senior Quality Systems Manager, eQMS Lead

Obsidian Therapeutics; Tennessee; Hybrid; USD 117,000 - 165,000; Full time

Benefits offered by this job

Annual incentive bonus

Stock options

Comprehensive benefits

Job summary

Obsidian Therapeutics is seeking a highly motivated Quality Systems Manager/Senior Manager, with a strong background in owning, maturing, and modernizing scalable Quality Systems. This hybrid role is based out of Bedford, MA, and will drive the eQMS program across Change Control, CAPA, Deviations, and QMR to ensure compliance and readiness for clinical-stage activities.

You will partner with cross-functional teams, develop governance, SOPs, and training materials, and lead continuous improvement

Qualifications

• Bachelor’s degree and 6+ years of QA experience in clinical late-stage biopharmaceutical environments.
• 3+ years of direct process ownership or administration of quality systems, including change control.
• Experience leading or playing a significant role in implementing an eQMS and regulatory compliance.

Responsibilities

• Manage the Quality Management System (QMS), serving as process owner for Change Control, Product Complaints, Deviations, 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.
• Establish and maintain governance processes, SOPs, and administration practices supporting ongoing system enhancements and continuous improvement.
• Own the Change Control program, including governance, process monitoring, effectiveness assessments, Change Control Review Board (CCRB) activities, and continuous improvement initiatives.
• Ensure deviations, investigations, CAPAs, product complaints, and vendor notifications are managed in a timely, compliant, and risk-based manner.
• Provide coaching and guidance to investigation owners on root cause analysis, risk assessment, and effective problem-solving methodologies.
• Monitor quality event closure timelines, extensions, recurring trends, and overall process effectiveness.
• Develop and maintain quality metrics, dashboards, scorecards, and executive-level reporting to support Quality Management Reviews.

Job description

Obsidian Therapeutics is seeking a highly motivated Quality Systems Manager/Senior Manager, with a strong background in owning, maturing, and modernizing scalable Quality Systems. This hybrid role is based out of Bedford, MA, and will drive the eQMS program across Change Control, CAPA, Deviations, and QMR to ensure compliance and readiness for clinical-stage activities.

You will partner with cross-functional teams, develop governance, SOPs, and training materials, and lead continuous improvement