Quality Systems Manager/Senior Manager

Our Opportunity...

We are looking for a highly motivated Quality Systems Manager/Senior Manager, with a strong background in owning, maturing, and modernizing scalable Quality Systems.  

A key contributor within Quality Systems & Compliance, you’ll implement Obsidian’s eQMS and serve as process owner for critical quality system processes including Change Control, Product Complaints, Deviations, CAPA, Vendor Notifications, and Quality Management Review, as we advance our first clinical stage autologous cell therapy program targeting solid tumors. 

As a member of our Technical Operations team, you will be a vital part of a highly collaborative group working to unlock the promise of precision cell therapy for patients, starting with our lead program amsoki-cel (OBX-115), a novel engineered tumor-infiltrating lymphocyte (TIL) cell therapy that uses our proprietary cytoDRiVE® platform. This is a unique opportunity to be a valuable contributor in a clinical-stage company with field-leading advisors, best-in-class partners, and an experienced team.     

This is a Hybrid role based out of our Bedford, MA location. 

You Will...

Core responsibilities

• 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. 
• 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. 

You Bring...

Core Qualifications

• Bachelor's degree and 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 
• 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.   
• Ability 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 
• Curious and humble – seeks and welcomes input/expertise of others, continuous learner  
• Tenacious and resilient – is not easily overwhelmed by challenges, delivers on commitments, operates with urgency. 

Bonus Qualifications

• Experience leading full eQMS implementation as business process owner 
• Strong project management and organizational skills 
• Ability to influence cross-functional teams without direct authority