Sr. Director, US Quality Assurance

Scholar Rock is seeking an experienced Senior Director of US Quality Assurance to provide strategic and operational leadership for US Quality Assurance with a strong focus on external partner governance, quality risk management, and scalable quality infrastructure.

Requirements

• Lead the US Quality Assurance function for external GxP biologics operations
• Provide QA oversight for external manufacturing, testing, release support, deviations, investigations, CAPAs, change controls, product impact assessments, and disposition-related decisions
• Design and maintain a robust, scalable product disposition program
• Ensure continuous inspection readiness across outsourced operations and support health authority inspections, partner inspections, and due diligence activities
• Monitor partner quality performance through defined metrics, scorecards, and governance forums; identify trends and proactively escalate compliance or execution risks
• Partner cross-functionally to assess quality risk associated with process changes, deviations, investigations, comparability activities, tech transfer, and supply continuity issues
• Provide strategic guidance on quality requirements for product lifecycle activities
• Build and develop internal QA capabilities, processes, and team structure appropriate for a virtual biotech operating model
• Drive a culture of quality, accountability, and proactive issue identification across internal stakeholders and external partners
• Collaborate with the Head of Quality and site leadership to ensure alignment with corporate goals, customer expectations, and regulatory obligations

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Tuition Reimbursement