Senior Manager, Quality Compliance

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. 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, execute internal audits and support regulatory inspections as necessary, onboard and qualify new suppliers, and establish Quality Agreements with suppliers. Champion a proactive quality culture focused on accountability, transparency, and risk-based decision-making. Up to 30% business travel (essential requirement).