Manager, Quality Operations

Our Opportunity… 

We’re looking for a motivated, experienced, purpose driven individual for the Manager, Quality Operations position.  In this role, you’ll be responsible for planning, coordinating, and executing critical quality initiatives that ensure full compliance with applicable regulatory requirements and support corporate objectives. As a key member of the Quality Assurance organization, you’ll provide quality oversight of CDMO manufacturing of our drug product as well as other critical materials used in GMP-regulated environments.

As part of the Quality team, you’ll collaborate closely cross-functionally and with internal teams and external partners to support Obsidian Therapeutics’ mission of  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 position is a hybrid role based out of our Bedford, MA office (work on-site is optional except as required for training, team meetings, and other essential activities)

You will… 

• Support oversight of CDMOs to ensure adherence to Good Manufacturing Practices (GMP) regulations as well as Obsidian Therapeutics’
• Participate in Person in Plant activities.
• Provide QA support for manufacturing operations including CMC, QA operations, and Supply chain and materials management.
• Manage lot disposition - review batch data including batch records, deviations, in-process data, EM data, QC release testing and other quality systems as applicable to determine acceptability of product disposition.
• Manage archive of batch records and other disposition supporting documents in internal document/record repositories.
• Provide QA support for change controls, GMP investigations, associated CAPAs and Effectiveness Checks.
• Facilitate resolution of Quality issues in a timely manner.
• Lead the investigation/CAPA triage meetings (as necessary) and collaborate with CDMO and internal partners to ensure quality systems are monitored and established metrics are met.
• Participate in IND preparedness, inspection readiness activities, and support regulatory site inspections.
• Support development of quality metrics
• Participate in process improvement initiatives, perform gap analyses and communicate risks.
• Provide compliance guidance to Obsidian project teams through collaborative review and working with the business owners to gain a better understanding of their needs
• Review applicable Supplier Quality Agreements.
• Travel up to 20% to perform essential functions of the job

You bring… 

Core Qualifications 

• Bachelor’s degree in Biology, Chemistry, Engineering, life sciences or a related field, and 6+ years of relevant work experience (or M.S. and 4+ years of relevant work experience).
• Strong knowledge of , SOPs, associated CMC regulatory considerations and quality system processes.
• Proficiency in providing QA support and oversight of GMP manufacturing operations including batch release, experience with CDMO manufacturing and testing. 
• Prior success in quality to quality interactions with CDMOs / CTLs Successful experience event investigations, Root Cause Analysis (RCA), and CAPA.
• Experience with both paper and electronic QMS systems. Contribution to the implementation of an electronic QMS system is a bonus.
• 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   
• Ability to manage and deliver multiple projects in a fast-paced environment.
• A systems thinker. Approaches problem solving and process design from consideration of the overall system as well as its individual parts; considers interrelationships and patterns.
• Demonstrates context-based sound judgement.