Enliven Therapeutics

QA Engineer

• Lead development, implementation, governance, and continuous improvement of the Company’s pharmaceutical quality system
• Provide independent Quality oversight of manufacturing, testing, packaging, labeling, storage, and distribution performed by external partners
• Serve as final Quality authority for batch disposition and release within delegated responsibilities
• Review and approve batch records, analytical results, deviations, investigations, change controls, CAPAs, specifications, validation documentation, and other product-quality records
• Oversee process and analytical changes, technology transfers, validation activities, new product introductions, product acquisitions, and post-approval changes
• Establish and maintain risk-based qualification, auditing, monitoring, and requalification programs for GxP suppliers
• Establish quality agreements and governance processes with external partners
• Monitor quality performance through metrics, management review, trend analysis, and partner governance
• Lead regulatory inspection readiness and serve as primary Quality representative during inspections and health-authority interactions
• Oversee inspection responses and remediation commitments
• Ensure oversight of data integrity, electronic records, computerized systems, and documentation practices
• Lead or support critical quality events, investigations, complaints, recalls, market actions, and regulatory notifications
• Provide Quality expertise for business-development due diligence, licensing, acquisitions, investigator-initiated studies, and promotional review
• Develop and manage the Quality Affairs budget, organizational capabilities, resource plans, and external support
• Build and lead a high-performing Quality organization and foster a culture of quality, accountability, compliance, transparency, and continuous improvement

Explore Senior Director, GMP Quality Assurance at Enliven Therapeutics. Review requirements and application details.