Obsidian Therapeutics

Operations

• Support oversight of CDMOs to ensure adherence to Good Manufacturing Practices (GMP) regulations as well as Obsidian Therapeutics’ standards
• 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.

Quality Operations Manager

Compliance

• 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)

Quality Operations Manager

Senior Manager, Quality Compliance