Quality Associate, QA Operations

Our Opportunity...

We’re growing our team to support the advancement of our clinical studies, and seeking a motivated, purpose‑driven individual for a Quality Associate, Quality Assurance Operations position. As a member of the Quality Assurance organization, this role provides QA support of CDMO drug product manufacturing, as well as other critical materials used in GMP‑regulated environments to ensure compliance with applicable regulatory requirements, deliver for our patients, and achieve company goals. 

You’ll be a vital part of a highly collaborative team working to achieve Obsidian’s vision by translating innovative science into medical breakthroughs for patients starting with our lead program OBX-115, a novel engineered tumor-infiltrating lymphocyte (TIL) therapy.   

This is a unique opportunity to be a contributor in a well-funded clinical company with blue chip investors, field-leading advisors, best-in-class partners, and an experienced team. You'll help us build a dynamic, innovative, passionate, collaborative, and successful organization focused on delivering transformative therapies in areas of greatest clinical need. 

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

You Will...

Core responsibilities

• Support QA Operations CDMO point person to ensure CDMO adherence to Good Manufacturing Practices (GMP), applicable regulations, and Obsidian Therapeutics policies.  
• Serve as a point of coordination for QA support across manufacturing operations by partnering with CMC, QA Operations, and Supply Chain/materials management teams to review documentation, resolve quality-related questions, and support timely execution of GMP activities. 
• Review batch data (e.g., batch records, deviations, in‑process data, EM data, QC release testing, and other quality systems as applicable) and escalate issues as needed to support product disposition decisions.  
• Maintain and archive batch records and other disposition supporting documents in internal document/record repositories, ensuring completeness, accuracy and audit readiness.  
• Provide timely QA support for change controls, GMP investigations, associated CAPAs, and effectiveness checks by reviewing records, supporting impact assessments, tracking action items, and helping ensure quality system activities are completed accurately and within required timelines. 
• Participate in IND preparedness and inspection readiness activities and provide QA support during regulatory site inspections, including follow up activities. 
• Contribute to process improvement initiatives, including gap analysis and risk communication.  
• Support Supplier Quality Agreement review activities by identifying needed updates, clarifications, and follow-up actions and coordinating input from relevant internal stakeholders. 
• Estimated travel: 10–20%. 

You Bring...

Core Qualifications

• Bachelor’s degree in biology, chemistry, engineering, life sciences or a related field, and 2+ years of relevant work experience (or M.S. and 1+ years of relevant work experience). Work experience in QA, QC, or Manufacturing preferred. 
• Experience supporting lot disposition activities by reviewing batch data (e.g., batch records, deviations, in‑process data, EM data, QC release testing, and other quality systems. 
• Experience supporting event investigations, Root Cause Analysis.   
• Understanding of cGMP's and associated CMC regulatory considerations. 
• Knowledge of cGMP, SOPs, and quality system processes. 
• 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 at all levels within and across internal teams, and with external partners.   
• 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 – continuous learner, seeks and welcomes input/expertise of others 
• Tenacious and resilient – is not easily overwhelmed by challenges, delivers on commitments, operates with urgency.