Senior Manager, Quality Compliance

Our Opportunity… 

We’re looking for a Senior Manager, Quality Compliance with a strong background in quality compliance, external and internal audits, supplier management, and regulatory inspections to contribute to strengthening Obsidian’s overall Quality Management System. In this role, you’ll work collaboratively and cross-functionally to manage Obsidian’s network of GMP suppliers.  

As a member of our Quality team, you'll be a vital part of a highly collaborative team working to achieve the 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 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… 

• Own the Quality Compliance and Audit programs to ensure alignment with FDA, ICH, and applicable GxP regulations; maintain phase-appropriate and risk-based quality systems across Technical Operations, Supply Chain, and Quality functions as well as with GMP CDMO suppliers 
•  Prepare for, schedule, and conduct audits of Obsidian’s GMP suppliers including CDMOs, contract testing laboratories, logistics providers, and other suppliers; generate an audit report and report findings to management and impacted stakeholders 
• Follow up with audit findings to ensure effective remediation and CAPA execution, ensuring overall supplier performance 
• Trend audit findings to identify systemic issues and improvement opportunities, and report at Management Review 
• Execute internal audits and support regulatory inspections as necessary 
• Onboard and qualify new suppliers and establish Quality Agreements with suppliers as necessary 
• Regularly maintain the Approved Supplier List 
• Author, review, and maintain SOPs governing Supplier Management, Audits, Quality Agreements, Supplier Corrective Action Requests, and Regulatory Inspections 
• Champion a proactive quality culture focused on accountability, transparency, and risk-based decision-making 
• Up to 30% business travel (essential requirement) 

You bring… 

Core Qualifications 

• Bachelor’s degree in Life Sciences, Engineering, or a related discipline with 8+ years of relevant work experience (or M.S. and 6+ years of experience). 
• 4+ years of biopharmaceutical experience in a related Quality function, cell or gene therapy strongly preferred 
• Direct auditing experience of GMP suppliers such as CDMOs or contract testing laboratories, cell or gene therapy preferred 
• Experience in clinical-stage environments 
• Excellent knowledge and understanding of applicable GXP regulations 
• Strong record-keeping and organizational skills, including an ability to manage multiple responsibilities in parallel 
• A highly collaborative working style. You build trusting relationships, invite and share ideas and feedback, productively challenge your own and others’ assumptions to generate new ideas and facilitate better outcomes.  

Bonus qualifications 

• Certified Quality Auditor (CQA) certification